Ortho-Clinical Diagnostics Recalls VITROS CK-MB Calibrators Due to Invalid Results
Ortho-Clinical Diagnostics is recalling VITROS CK-MB Calibrators because internal testing found that improperly stored units generated invalid calibrations.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because the product is unlikely to cause adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products CK-MB Calibrators (REF 128 6293). The recall involves specific lots with expiration dates ranging from April 2013 to January 2014. The product is intended for use in the calibration of VITROS ECi/ECiQ, 3600, and 5600 Immunodiagnostic Systems for the quantitative measurement of CK-MB in human serum and plasma.
Internal testing demonstrated that opened and reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Fahrenheit) generated invalid calibrations. These invalid calibrations were detected by positively biased quality control results. The recall covers 3,019 domestic units and 905 foreign units distributed worldwide, including the United States, Puerto Rico, and various international locations.
Healthcare facilities and laboratories should stop using the affected calibrators and contact Ortho-Clinical Diagnostics for further instructions. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Syst
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots 1400 (exp. 22 April 2013)
- 1410 (exp. 20 May 2013)
- 1420 (exp. 12 July 2013)
- 1430 (exp. 5 August 2013)
- 1440 (exp. 10 September 2013)
- 1450 (exp. 18 November 2013)
- 1460 (exp. 18 November 2013)
- 1465 (exp. 13 November 2013)
- 1480 (exp. 3 January 2014)
Distribution
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