Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results
Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagents because they may produce false reactive results when used with Remel M4RT Viral Transport Media.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk diagnostic product where the hazard is false reactive results, which can lead to incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent. This in vitro diagnostic is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal specimens. The recall is limited to any lot used with Remel M4RT Viral Transport Media (VTM).
The recall is being conducted because the reagent may produce false reactive results when used in combination with the specified Remel M4RT VTM. 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.
Healthcare facilities and laboratories that have used or possess this product should stop using it immediately. Users should contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the affected units.
The recalled product
- 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…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Affected units
- 2,782
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.
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