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

Cybersecurity Review

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