SARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.
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: FDA Class II recall for medical device calibrators that may generate false positive test results, potentially leading to incorrect diagnosis. No illnesses or injuries have been reported; this is classified as a risk-of-harm product without documented injury per the rubric.
Plain-English summary
Beckman Coulter Inc. has recalled Access SARS-CoV-2 Antigen Calibrators (Catalog REF: C68669) used in diagnostic testing. The calibrator kit contains 1x2.5 mL C0, 1x2.5 mL C1, and 1 calibration card. Approximately 451 units with all lot numbers have been affected.
The SARS-CoV-2 Antigen Assay test using these calibrators may generate false positive results. This could result in incorrect diagnosis, meaning patients could be falsely identified as having COVID-19 when they do not.
The recalled calibrators were distributed nationwide in the United States and internationally to New Zealand and Libya.
Beckman Coulter and the FDA recommend that healthcare facilities and testing laboratories using these calibrators discontinue use and contact the manufacturer for instructions on returns or replacement products. No illnesses or injuries have been reported as a result of this issue.
The recalled product
- Product
- Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 451
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
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter 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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