VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro… — Class II medical device recall Z-1266-2021

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-1266-2021`
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	2,782 units
UPC / GTIN / UDI-DI	`10758750033584`

Product

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. 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). Intended for Use in the United States Product Code: 6199949.

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-1266-2021. 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.