VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack — Class II medical device recall Z-0772-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-01-31, distributed nationwide. Affected lots may experience increased calibration failures or an increase in falsely elevated results.
| Recall number | Z-0772-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2023-11-27 |
| Classified | 2024-01-19 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750001682 |
| Lot numbers | 8931, 8940, 8955, 8960, 8970, 8980, 8990 |
| Model numbers | 6801925, 6801926 |
Product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Reason for recall
Affected lots may experience increased calibration failures or an increase in falsely elevated 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-0772-2024. 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.