Beckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk
Beckman Coulter is recalling Access SARS-CoV-2 Antigen test kits because specimens stored in certain conditions may yield false negative results.
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 device where the hazard (false negatives) has not yet resulted in reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Beckman Coulter Inc. is recalling the Access SARS-CoV-2 Antigen test (REF C68668) due to a potential for false negative results. The recall affects 1,034 units distributed worldwide, including nationwide distribution in the United States and in New Zealand.
The recall is issued because specimens collected in transport media may result in false negative results when stored in certain conditions. This issue could lead to incorrect diagnostic outcomes for patients tested with the affected kits.
Healthcare providers and facilities that have received this product should stop using it immediately. Users should contact Beckman Coulter Inc. for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1,034
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)
- All Lots
Distribution
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