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
Read the official notice →- Date
- 2023-05-31
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating…
- Classification
- Class II
- Units
- US Nationwide and Worldwide Distribution Foreign: Argentina Australia…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-06
USSiemens 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 → - 2023-05-10
- 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 →
Other drugs & medical recalls in the United States
- 2023-06-07
- US
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,…
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed to 32 clinics in SC, NC and VA.Official notice → - US
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
FDA · DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterProduct was distributed in Missouri.Official notice → - US
Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated,…
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- 2023-05-31
- US
Arjohuntleigh Magog, Inc. recalls Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting…
Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c…
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil…Official notice → - US
Binx Health, Inc. recalls binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results