Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 1/28/2015
Class lI:
PRODUCT
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 – in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 – in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Recall Number Z-1004-2015
REASON
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 9/29/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Internationally
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