Advia Cantaur and ACS:180 Insulin Calibrator

• 2 recalls, same reason

  • Terminated Z-2085-2017 FDA Class II ·initiated 5 Apr 2017
  • Terminated Z-2086-2017 FDA Class II ·initiated 5 Apr 2017 ·on shared 510(k) K021535

  Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021535 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

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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