Recall – Clinical chemistry analyzer calibration error

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

PRODUCT

VITROS 250 Chemistry System, clinical chemistry analyzer

  • Recall Number: Z-2174-2019
  • Recall Number: Z-2175-2019

VITROS 250AT Chemistry System, clinical chemistry analyzer

  • Recall Number: Z-2176-2019

VITROS 350 Chemistry System, clinical chemistry analyzer

  • Recall Number: Z-2177-2019

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

  • Recall Number: Z-2178-2019

VITROS 5600 Integrated System, clinical chemistry analyzer

  • Recall Number: Z-2179-2019
  • Recall Number: Z-2180-2019

VITROS 4600 Chemistry System, clinical chemistry analyzer

  • Recall Number: Z-2181-2019
  • Recall Number: Z-2182-2019

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

  • Recall Number: Z-2183-2019
  • Recall Number: Z-2184-2019

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

  • Recall Number: Z-2185-2019

REASON

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

RECALLING FIRM/MANUFACTURER

Ortho Clinical Diagnostics on 7/8/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

30

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.