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

___________________________________