Recall – Modifications to IDS parameters not retained

Company: Ortho Clinical Diagnostics
Date of Enforcement Report: 7/8/2020
Class II

PRODUCT

VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

Recall Number: Z-2480-2020

REASON

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

RECALLING FIRM/MANUFACTURER

Ortho Clinical Diagnostics on 7/20/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

779 (U.S. = 225  OUS = 554)

DISTRIBUTION

U.S. Nationwide and International

Corporate Office

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