VITROS SARS-CoV-2 Antigen Reagent Pack — Class II medical device recall Z-1267-2021
Terminated recall by Ortho-Clinical Diagnostics, Inc., reported 2021-03-24, distributed nationwide. VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Vi
| Recall number | Z-1267-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2021-02-12 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, CO, DE, DK, ES, FR, GB, IN, IT, JP, PT, RU, SG |
| Quantity | 12,177 units |
| UPC / GTIN / UDI-DI | 10758750033584 |
Product
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product.
Reason for recall
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
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-1267-2021. 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.