Company: Ortho Clinical Diagnostics Inc
Date of Enforcement Report: 8/14/2019
Class II

PRODUCT

ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577

Recall Number: B-0800-2019

ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576

B-0801-2019

REASON

Ortho Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers with a pipetting probe anomaly associated with software version 5.12.3 and 5.12.4, were distributed.

RECALLING FIRM/MANUFACTURER

Ortho Clinical Diagnostics Inc on 7/15/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

• 1117 analyzers

DISTRIBUTION

US Nationwide and International