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