Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and II

• • Terminated Z-0971-2012 FDA Unclassified (pre-2012) ·initiated 27 Oct 2011 ·on shared 510(k) K042643

  Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.

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

510(k) Number

K042643 ↗

FDA Product Code

DCF

Device Class

Class II

Regulation

21 CFR Part 866.5040

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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