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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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