Additional Assays for the Bayer Advia 1650 Chemistry System

• • Ongoing Z-1498-2022 FDA Class II ·initiated 28 Jun 2022 ·on shared 510(k) K991576

  Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

• • Terminated Z-2062-2018 FDA Class II ·initiated 27 Mar 2018 ·on shared 510(k) K991576

  Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

• • Terminated Z-1658-2016 FDA Class II ·initiated 17 Mar 2016 ·on shared 510(k) K991576

  Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

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

510(k) Number

K991576 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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