Kodak Ektachem Dt Slides (Urcr)

• • Terminated Z-0917-2012 FDA Unclassified (pre-2012) ·initiated 13 Oct 2011 ·on shared 510(k) K934071

  Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal investigation and confirmed that negatively biased NBIL results could occur for quality control, proficiency and patient samples. As a result, VITROS Chemistry Products DT Calibrator Kit Lots 37 &

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

510(k) Number

K934071 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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