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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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