Dec

2018

Recall – IVD Software anomaly

Company: Ortho-Clinical Diagnostics
Date of Enforcement Report: 12/20/18
Class II

PRODUCT

VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Recall Number: Z-0650-2019

REASON

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

RECALLING FIRM/MANUFACTURER

Ortho-Clinical Diagnostics, Rochester, NY on 10/19/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2413

DISTRIBUTION
U.S. Nationwide

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