Recall – Blood bank analyzer anomaly with certain software versions

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

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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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