Company:Ortho-Clinical Diagnostics
Date of Enforcement Report:6/18/2014
Class lI:
PRODUCT
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Recall Number Z-1734-2014
REASON
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 4/10/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Domestic – 82, Foreign – 213 units
DISTRIBUTION
Nationwide and Internationally
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