Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2240-2020·Announced 2020-06-10

Beckman Coulter Access Thyroglobulin Immunoassay Recalled for Biotin Interference

Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test 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, and the hazard involves potential test result bias due to biotin interference without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Beckman Coulter Inc. is recalling 95,453 units of Access Thyroglobulin immunoassay systems (REF 33860) for use with the Access Family of Immunoassay Systems. The recall affects all lots of the product.

The recall was initiated because the firm identified potential interference effects from biotin on the assay. Specifically, the Access Thyroglobulin assay displayed significant interference, defined as a result bias greater than +/-10%, at biotin levels of 1,200 ng/mL. This interference can lead to inaccurate test results.

The product was distributed across all 50 US states, the District of Columbia, and US territories, as well as numerous countries outside the United States. Healthcare facilities and laboratories using these systems should contact Beckman Coulter for further instructions on managing the recall.

The recalled product

Product: Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) 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 DxC 860i, and…
Manufacturer: Beckman Coulter Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: test-interference
biotin-interference
Affected units: 95,453

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: 33860
all lots.

Distribution

Distributed in 52 states:

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.

See all 6 products in this recall →

Same manufacturer · Beckman Coulter Inc.

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