Lower riskMedical device recall · FDA · Published February 12, 2021
Ortho-Clinical VITROS SARS-CoV-2 Antigen Test Kit May Give False Positives with Remel M4RT
Ortho-Clinical recalls VITROS SARS-CoV-2 Antigen Reagent Packs that may produce false positive results when used with Remel M4RT Viral Transport Media. Affected kits must be checked for specific product codes and lot numbers.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
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Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling VITROS SARS-CoV-2 Antigen Reagent Packs that can give false positive results when used with Remel M4RT Viral Transport Media. This could lead to incorrect test results and unnecessary anxiety or actions. Read more at govinfonow.com/recall/63268-ortho-clinical-vitros-sars-cov-2-antigen-test-kit-may.
“Ortho-Clinical VITROS SARS-CoV-2 Antigen Test Kit May Give False Positives with Remel M4RT.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63268-ortho-clinical-vitros-sars-cov-2-antigen-test-kit-may. Based on FDA recall #Z-1267-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2021%22&limit=1).
The FDA announced on Feb. 12, 2021, that Ortho-Clinical Diagnostics voluntarily recalled VITROS SARS-CoV-2 Antigen Reagent Packs due to false reactive results when used with Remel M4RT Viral Transport Media. The agency issued recall number Z-1267-2021 for the Class II device.
The VITROS SARS-CoV-2 Antigen Reagent Pack produces false reactive results when used in combination with Remel M4RT Viral Transport Media. The product is a chemiluminescent immunoassay intended for emergency authorization use only to detect SARS-CoV-2 nucleocapsid protein antigens.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Recent brand recalls include calibration failures affecting VITROS Chemistry Products LAC Slides reported on July 29, 2025, and Condition Code TH4-63J issues with VITROS Ca Slides reported on July 9, 2025. Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N447 Kit recall on June 4, 2026, and the Biomerieux VITEK 2 AST-N461 Test Kit recall on July 24, 2026.
How to tell if you have this one
Check for product code 6199941 and any lot numbers used with Remel M4RT Viral Transport Media. The kit is labeled as 'Emergency Authorization Use Only (EAU)' and has a unique identifier UDI: 10758750033584.
Brand
Ortho-Clinical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-1266-2021
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.; Any lot used with Remel M4RT VTM UDI: 10758750033584
2782 units
Z-1267-2021
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.; Any lot used with Remel M4RT VTM UDI: 10758750033584
12177 units
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for product code 6199941 on the kit label.
Verify Transport Media
Ensure the kit was not used with Remel M4RT Viral Transport Media.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1267-2021 (February 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1267-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.