Company:Ortho-Clinical Diagnostics.
Date of Enforcement Report 6/6/12
Class ll:

PRODUCT
VITROS 5600 Integrated System Software Version 1.6 & Below 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. Product code: 6802413. Recall # Z-1699-2012

REASON
Recall because of an anomaly that may inadvertently add a surfactant to a CurveTip position.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter dated April 26, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,357 units

DISTRIBUTION
Nationwide and Internationally

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