Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results
Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic device that may produce false reactive results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack. This recall involves 12,177 units of the product, which is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal specimens. The product was distributed worldwide, including in the United States, Australia, Belgium, Canada, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore, Spain, and the United Kingdom.
The recall is being conducted because the VITROS SARS-CoV-2 Antigen Reagent Pack may produce false reactive results when used in combination with Remel M4RT Viral Transport Media (VTM). The specific hazard is associated with any lot of the reagent pack used with this specific transport media. The product is authorized for emergency use only.
Healthcare facilities and laboratories that have used or possess this product should stop using the VITROS SARS-CoV-2 Antigen Reagent Pack with Remel M4RT VTM. Users should contact Ortho-Clinical Diagnostics for further instructions on how to handle the affected units and manage potential false reactive results.
The recalled product
- 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
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Affected units
- 12,177
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Any lot used with Remel M4RT VTM UDI: 10758750033584
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics, Inc.
See all →- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · false positive results
See all →- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- ModerateLeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
FDA (Devices) · 2026-04-29
- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- HighLeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
FDA (Devices) · 2026-04-29
- HighSolana Bordetella Complete Assay Kit Recalled for False Positive Results
FDA (Devices) · 2025-06-18