VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs — Class II medical device recall Z-0557-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-01-01, distributed nationwide. Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-
| Recall number | Z-0557-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-10-25 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2018-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,920 kits |
Product
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Reason for recall
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive 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-0557-2014. 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.