Siemens Healthcare Diagnostics recalls
80 official recalls and safety alerts involving Siemens Healthcare Diagnostics since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Siemens Healthcare Diagnostics or the relevant agency.
- 2026-10-07
USSiemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
The potential for falsely elevated results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →- 2026-08-26
- US
Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment,…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the country of…Official notice → - 2026-08-12
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E)…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA and VA. The country…Official notice → - 2026-07-15
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-06-17
- US
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-05-06
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Italy, Spain,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-04-08
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution International: Argentina, Australia,…Official notice → - 2026-03-11
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2025-11-19
- US
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice → - 2025-11-05
- US
Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number:…
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID,…Official notice → - 2025-09-17
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-08-13
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2025-08-06
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride,…
FDA · DeviceSiemens Healthcare Diagnostics Incworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2025-07-09
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA,…Official notice → - 2025-07-02
- US
Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.Official notice → - 2025-06-04
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-05-07
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software…
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
FDA · DeviceSiemens Healthcare Diagnostics IncDomestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia,…Official notice → - US
Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO,…Official notice → - 2025-04-16
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas,…Official notice → - 2025-01-01
- US
Siemens Healthcare Diagnostics, Inc. recalls Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained…
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain…Official notice → - 2024-12-11
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in…
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CI Analyzer. Catalog Numbers: 10947347.
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice → - 2024-11-27
- US
Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and…
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina…Official notice → - 2024-11-20
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution.Official notice → - 2024-11-13
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from…
- 2024-10-09
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice → - 2024-09-25
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human…
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH,…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-09-18
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distributionOfficial notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution. International: Austria, Belgium, Canada,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice → - 2024-07-03
- US
Siemens Healthcare Diagnostics Inc recalls Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas…
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and…Official notice → - 2024-05-29
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, CA, DC,…Official notice → - 2024-04-24
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium…
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-03-27
- US
Siemens Healthcare Diagnostics, Inc. recalls DCA Systems HbA1c Reagent Kit
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the country of Taiwan.Official notice → - 2024-03-20
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI,…Official notice → - 2024-02-14
- US
Siemens Healthcare Diagnostics, Inc. recalls Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2023-12-27
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice → - US
Siemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX),…
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…
- 2023-12-06
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The…
FDA · DeviceSiemens Healthcare Diagnostics IncDomestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola,…Official notice → - 2023-10-11
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- 2023-09-06
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
FDA · DeviceSiemens Healthcare Diagnostics IncUS distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human…
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Country Albania Algeria Argentina Australia Austria…Official notice → - 2023-08-30
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the…
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA,…Official notice → - 2023-07-12
- US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Storage and Retrieval Module (SRM)
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - 2023-05-31
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use…
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide and Worldwide Distribution Foreign: Argentina Australia…Official notice → - 2023-05-10
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number…
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice → - 2023-03-22
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus…
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile…Official notice → - 2023-03-15
- US
Siemens Healthcare Diagnostics Inc recalls epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2,…
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus…Official notice → - 2023-03-01
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and…
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection…
Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide distribution in the states of GA, UT.Official notice → - 2023-01-18
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/…
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice → - 2022-12-21
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the…
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿…Official notice → - 2022-12-14
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers…
Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY,…Official notice → - 2022-10-26
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide.Official notice → - US
SIEMENS HEALTHCARE DIAGNOSTICS INC recalls N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN):…
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result…
- 2022-10-05
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US;…
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results.…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice → - 2022-09-07
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice → - 2022-08-10
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and…
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS,…Official notice → - 2022-07-20
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or…
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
- 2022-07-13
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and…
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2022-06-15
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical…
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Albania,…Official notice → - 2022-05-11
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN:…
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2022-05-04
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number…
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2022-04-20
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Global Distribution. US Nationwide.Official notice → - 2022-04-06
- US
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension…
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ,…Official notice → - 2022-01-12
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to…
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE…Official notice → - 2022-01-05
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - 2021-12-08
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution and the countries of DE,…Official notice → - 2021-11-10
- US
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
FDA · DeviceSiemens Healthcare Diagnostics, IncUS Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1…
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical…
- 2021-11-03
- US
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice → - 2021-10-27
- US
Siemens Healthcare Diagnostics, Inc recalls Atellica IM 1600 Analyzer, SMN 11066000
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result,…
FDA · DeviceSiemens Healthcare Diagnostics, IncDomestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX…Official notice →