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