Recall – IVD Software anomaly, additional models

Company: Ortho-Clinical Diagnostics
Date of Enforcement Report: 12/20/18
Class II

PRODUCT

VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

Recall Number: Z-0651-2019 (VITROS 5.1)

Recall Number: Z-0652-2019 (VITROS 3600)

Recall Number: Z-0653-2019 (VITROS 4600)

REASON

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

RECALLING FIRM/MANUFACTURER

Ortho-Clinical Diagnostics, Rochester, NY on 10/19/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2413

DISTRIBUTION
U.S. Nationwide

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.