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…
Read the official notice →- Date
- 2023-01-18
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi)…
- Classification
- Class II
- Units
- Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Siemens Healthcare Diagnostics recalls
- 2023-03-15
USSiemens 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 → - 2022-12-21
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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
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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 →
Other drugs & medical recalls in the United States
- 2023-01-18
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Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA · DeviceMedtronic Navigation, Inc.US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN,…Official notice → - US
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information…
FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice → - US
Depuy Ireland UC recalls BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size…
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general,…
FDA · DeviceDepuy Ireland UCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Stradis Healthcare recalls McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis HealthcareUS Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item…
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis MedBank System - Product Label/labeling pending
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO,…Official notice →