Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 10/22/2014
Class lI:

PRODUCT

VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Recall Number Z-0078-2015

REASON
Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 9/8/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
USA: 843; Foreign: 945

DISTRIBUTION
Nationwide and Internationally

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