Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 11/11/2015
Class lI:
PRODUCT
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest. Recall Number Z-0231-2016
REASON
Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, rochester, NY on 9/10/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Catalog # 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147
DISTRIBUTION
Nationwide and Internationally.
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