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

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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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15148 Springview St
Tampa, FL 33624
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+1-781-721-2921
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