Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on… — Class II medical device recall Z-1367-2022
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2022-07-20, distributed nationwide. On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instruction
| Recall number | Z-1367-2022 |
|---|---|
| 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 | 2022-05-26 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, IN, SG |
| Quantity | 20,858 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10758750034413 |
| Lot numbers | ANTI-SARS-COV-2 |
Product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Reason for recall
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
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-1367-2022. 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.