VITROS Immunodiagnostic Products Anti-HBc IgM Controls — Class III medical device recall Z-0247-2022
Terminated recall by Ortho-Clinical Diagnostics, Inc., reported 2021-11-24, distributed in AZ, CA, CO, CT, FL, GA, LA, MA…. Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Contr
| Recall number | Z-0247-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2021-10-15 |
| Classified | 2021-11-17 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-12-18 |
| Distributed | AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, WV |
| Countries outside the US | CO |
| Quantity | 191 units |
| UPC / GTIN / UDI-DI | 10758750001200 |
| Lot numbers | 1690 |
Product
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Reason for recall
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of 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-0247-2022. 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.