Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 5/6/2015
Class lI:

PRODUCT

Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.
Recall Number Z-1521-2015

REASON
Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 3/10/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
VITROS 5.1 System: Domestic – 909; Foreign – 1250; 5,1 Refurbished: Domestic – 66 units, Foreign – 152

DISTRIBUTION
Nationwide and Internationally

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