VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immu...

FDA Device Recall #Z-1266-2021 — Class II — February 12, 2021

Recall Summary

Recall Number Z-1266-2021
Classification Class II — Moderate risk
Date Initiated February 12, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho-Clinical Diagnostics, Inc.
Location Rochester, NY
Product Type Devices
Quantity 2782 units

Product Description

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

Distribution Pattern

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.

Lot / Code Information

Any lot used with Remel M4RT VTM UDI: 10758750033584

Other Recalls from Ortho-Clinical Diagnostics, Inc.

Recall # Classification Product Date
Z-2559-2025 Class II Chemistry Products LAC Slides. Catalog Number: ... Jul 29, 2025
Z-2560-2025 Class II VITROS Chemistry Products LAC Slides. Catalog N... Jul 29, 2025
Z-2335-2025 Class II VITROS Chemistry Products Ca Slides; Catalog N... Jul 9, 2025
Z-2073-2025 Class II VITROS Chemistry Products OP Reagent Gen 15. Mo... Jun 12, 2025
Z-2121-2025 Class II Brand Name: VITROS Chemistry Products Product ... Jun 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.