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