Beckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference
Beckman Coulter is recalling Access Thyroglobulin Antibody II 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 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 is classified as FDA Class II, and the hazard involves significant test result bias due to biotin interference, which poses a risk of harm through misdiagnosis or treatment errors, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Beckman Coulter Inc. is recalling the Access Thyroglobulin Antibody II (REF A32898) immunoassay system. The recall involves 123,324 units distributed across the United States, US territories, and numerous international locations. The product is used with the Access Family of Immunoassay Systems, including the Access 2, UniCel DxI 600, and various UniCel DxC models.
The recall was initiated because the firm characterized potential interference effects of biotin on biotin-mediated Access assays. The Access Thyroglobulin Antibody II assay displayed significant interference, defined as a result bias greater than +/-10%, at biotin concentrations of 1,200 ng/mL. This interference can lead to inaccurate test results.
Healthcare facilities and laboratories using these systems should stop using the affected product and contact Beckman Coulter for further instructions. The recall covers all lots of Catalog Number A32898.
The recalled product
- Product
- Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with 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…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 123,324
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: A32898
- 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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