Reported May 29, 2013 · Terminated
VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12…
Ortho-Clinical Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 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 System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).
- Lot codes and dates
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)
- Amount recalled
- Domestic: 3019 units, Foreign: 905 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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