# FDA recall Z-1267-2021

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2021-02-12.

## 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

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Canada L3R 4G5, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore 609917, Spain, United Kingdom.

## Key facts

- **Recall number:** Z-1267-2021
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-12
- **Report date:** 2021-03-24
- **Termination date:** 2022-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2021

## Citation

> AI Analytics. FDA recall Z-1267-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1267-2021. Source: US FDA. Licensed CC0.

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