VITROS Immunodiagnostic Products CK-MB Calibrators — Class III medical device recall Z-1337-2013

Terminated recall by Ortho-Clinical Diagnostics, reported 2013-05-29, distributed nationwide. Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius

Recall number	`Z-1337-2013`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ortho-Clinical Diagnostics, Rochester, NY, United States
Recall initiated	2013-04-03
Classified	2013-05-17
Reported by FDA	2013-05-29
Terminated	2017-03-02
Distributed	Nationwide (US)
Countries outside the US	AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE
Lot numbers	`1400`
Model numbers	`128`, `6293`
Expiration dates	`2013-04-22`, `2013-05-20`, `2013-07-12`, `2013-08-05`, `2013-09-10`, `2013-11-13`, `2013-11-18`, `2014-01-03`

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 System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1337-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.