Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2238-2020·Announced 2020-06-10

Beckman Coulter Free T3 Immunoassay Recalled for Biotin Interference

Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of 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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for inaccurate test results due to biotin interference, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/interference issues without reported harm.

Plain-English summary

Beckman Coulter Inc. is recalling 418,400 units of Access Free T3 Triiodothyronine assays (REF A13422) for use with the Access Family of Immunoassay Systems. The recall affects all lots of the product.

The recall was initiated because the firm characterized potential interference effects of biotin on biotin-mediated Access assays. The source text indicates that the Free T3 assay displayed significant interference, defined as a result bias greater than +/-10%, at 1,200 ng/mL of biotin. This interference can lead to inaccurate test results.

The product was distributed in all 50 US states, the District of Columbia, and US territories including American Samoa, Guam, and Puerto Rico. It was also distributed in numerous countries outside the United States. Consumers and healthcare providers should stop using the affected assays and contact Beckman Coulter for further instructions.

The recalled product

Product: Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) 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.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
inaccurate-results
Affected units: 418,400

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: A13422
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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Same hazard · biotin interference