Agency classClass IIOur severity:High FDA (Devices)·Z-2237-2020·Announced 2020-06-10

Beckman Coulter Access Free T4 Thyroxine Assay Recalled for Biotin Interference

Beckman Coulter is recalling Access Free T4 Thyroxine assays because biotin can cause significant result bias, potentially affecting patient care.

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 involves a medical device where a known interference (biotin) can lead to significant result bias (>10%), posing a risk of incorrect diagnosis or treatment, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling the Access Free T4 Thyroxine assay (REF 33880) for use with the Access Family of Immunoassay Systems. The recall involves 1,322,438 units distributed across all 50 U.S. states, U.S. territories, and numerous countries outside the United States.

The recall was initiated because the firm identified that biotin at concentrations up to 1,200 ng/mL can cause significant interference with the assay. Significant interference is defined as a result bias greater than +/-10%. This specific assay, along with five other biotin-mediated Access assays, displayed this level of interference at the specified biotin concentration.

Healthcare facilities and laboratories using these systems should stop using the affected assays and contact Beckman Coulter for further instructions. Patients who have had recent thyroid testing should consult their healthcare provider to discuss the potential impact of biotin interference on their results.

The recalled product

Product: Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with 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: biotin-interference
mis-diagnosis
Affected units: 1,322,438

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: 33880
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