Recall – IVD Software anomaly

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

PRODUCT

VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Recall Number: Z-0650-2019

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

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.