Acs: 180 and Advia Centaur Anti-Thyroglobulin Immunoassays

• 4 recalls, same reason

  • Terminated Z-1236-2019 FDA Class II ·initiated 7 Dec 2018
  • Terminated Z-1235-2019 FDA Class II ·initiated 7 Dec 2018
  • Terminated Z-1233-2019 FDA Class II ·initiated 7 Dec 2018
  • Terminated Z-1234-2019 FDA Class II ·initiated 7 Dec 2018

  Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).

510(k) Number

K012777 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Estradiol Assay for the Technicon Immuno 1 System in-Vitro Diagnostic System

  Class I

  FDA 510(k) K951360 Active Cleared 2 May 1995

• Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System

  Class II

  FDA 510(k) K022288 Active Cleared 17 Dec 2002

• 8 Additional Assays for the Bayer Advia 1650 Chemistry System Open recall

  Class I

  FDA 510(k) K992662 Active Cleared 15 Feb 2000

• Clinitek Hcg Test Strips

  Class II

  FDA 510(k) K971209 Active Cleared 4 Apr 1997

• Bayer Diagnostics ACS:180 VB12, Bayer Diagnostics Advia Centaue VB12

  Class II

  FDA 510(k) K993571 Active Cleared 16 Dec 1999

• Glucometer Elite Xl Blood Glucose Meter

  Class II

  FDA 510(k) K990649 Active Cleared 9 Jul 1999

See all devices from Bayer Corp. →