Drugs & medicalClass II

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.

Read the official notice →
Date
2023-05-10
Country
United States
Brand
Siemens Healthcare Diagnostics
Product
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro…
Classification
Class II
Units
Worldwide distribution - US Nationwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2023-08-30
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    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 →
  3. 2023-07-12
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    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 →
  5. 2023-05-31
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    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 →
  7. 2023-03-22
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    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 →
  9. 2023-03-15
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    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 →
  11. 2023-03-01
  12. US
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    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 →
All 80 Siemens Healthcare Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2023-05-10
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    Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…

    MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

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    Spacelabs Healthcare, Inc. recalls Ultraview SL (UVSL) Command Module, Model 91496

    Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent…

    FDA · DeviceSpacelabs Healthcare, Inc.US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR,…Official notice →
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    GE Healthcare recalls Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e)…

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See all drugs & medical recalls →