The Recall Desk
ModerateFDA (Devices)·Z-2635-2017·Announced 2017-07-05

Beckman Coulter Access Total T3 Immunoassay Recalled for Biotin Interference

Beckman Coulter is recalling Access Total T3 immunoassays because they are susceptible to biotin interference, which may affect test results.

What this means for you

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 deaths. The hazard is a susceptibility to interference rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling the Access Total T3 immunoassay (Catalog No. 33830, A34435H). The recall involves 313,158 units total, with 43,725 units distributed in the United States. The product was distributed to numerous countries worldwide, including the United States, Canada, and various nations in Europe, Asia, Africa, and the Americas.

The recall was initiated because the Access immunoassays are susceptible to biotin interference. This susceptibility may impact the accuracy of the test results. The source text does not specify reported illnesses, injuries, or deaths associated with this recall.

Healthcare providers and laboratories using this product should stop using the affected units 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
Access Total T3, A34435H, Catalog No. 33830
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (1)

  • all lots

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · biotin interference

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