Bayer Diagnostics ACS:180 and Advia Centaur Anti-Tpo Assay

• 2 recalls, same reason

  • Ongoing Z-3304-2024 FDA Class II ·initiated 21 Aug 2024
  • Ongoing Z-3305-2024 FDA Class II ·initiated 21 Aug 2024

  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.

510(k) Number

K003291 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Salicylate Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K020794 Active Cleared 11 Jul 2002

• Bayer Special Chemistry Controls

  Class I

  FDA 510(k) K033379 Active Cleared 19 Dec 2003

• Ammonia Assay for the Advia 1650

  Class I

  FDA 510(k) K023841 Active Cleared 24 Dec 2002

• Uric Acid Assay for the Advia Integrated Modular System

  Class I

  FDA 510(k) K022096 Active Cleared 18 Mar 2003

• Bayer Special Chemistry Calibrators

  Class II

  FDA 510(k) K033380 Active Cleared 16 Dec 2003

• Ca 15-3 Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K022178 Active Cleared 12 Nov 2002

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