VITROS CA 125 II Calibrators For use in the calibration of the VITROS… — Class II medical device recall Z-0525-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-12-25, distributed nationwide. Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 12
| Recall number | Z-0525-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-10-09 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2018-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Quantity | 601 units |
| Lot numbers | 1220, 1230, 1240, 1250 |
Product
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
Reason for recall
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient 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-0525-2014. 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.