Vitros Chemistry Products Dtibc Reagent

• • Terminated Z-2119-2016 FDA Class III ·initiated 24 May 2016

  Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.

510(k) Number

K052867 ↗

FDA Product Code

JMO

Device Class

Class I

Regulation

21 CFR Part 862.1415

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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