Company: Ortho-Clinical Diagnostics
Date of Enforcement Report: 12/20/18
Class II
PRODUCT
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Recall Number: Z-0651-2019 (VITROS 5.1)
Recall Number: Z-0652-2019 (VITROS 3600)
Recall Number: Z-0653-2019 (VITROS 4600)
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