Beckman Coulter Access GI Monitor Cancer Antigen 19-9 Recalled for Biotin Interference
Beckman Coulter is recalling Access GI Monitor Cancer Antigen 19-9 assays because biotin can cause significant result bias.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a potential for inaccurate results due to biotin interference rather than a direct physical injury or reported illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the Access GI Monitor Cancer Antigen 19-9 assay (REF 387687) used with the Access Family of Immunoassay Systems. The recall involves 150,887 units distributed across all 50 U.S. states, U.S. territories, and numerous international locations.
The recall is due to potential interference from biotin. The manufacturer characterized that biotin levels up to 1,200 ng/mL can cause significant interference in this assay, defined as a result bias greater than +/-10%. This interference may lead to inaccurate test results.
Healthcare facilities and laboratories should stop using the affected assays and contact Beckman Coulter for further instructions. Consumers should consult their healthcare providers regarding any recent test results that may have been affected by this issue.
The recalled product
- Product
- Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 150,887
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 (2)
- Catalog Number: 387687
- all lots.
Distribution
Part of a larger recall action
This product is one of 6 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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