Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 1/21/2015
Class lI:
PRODUCT
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-0967-2015
REASON
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration..
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 11/19/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
658 total: USA – 144, Foreign – 514
DISTRIBUTION
Nationwide and Internationally
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