Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 1/20/2016
Class lI:
PRODUCT
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: 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-0641-2016
REASON
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, rochester, NY on 11/3/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Domestic: 1083, Foreign: 999
DISTRIBUTION
Nationwide and Internationally.
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