The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2239-2020·Announced 2020-06-10

Beckman Coulter Access Total T3 Assay Recalled for Biotin Interference

Beckman Coulter is recalling Access Total 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, and the hazard involves potential diagnostic inaccuracy due to biotin interference without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling the Access Total T3 Triiodothyronine assay (REF 33830) for use with the Access Family of Immunoassay Systems. The recall involves 238,862 units distributed across the United States, US territories, and numerous international locations.

The recall was initiated because the firm characterized the potential interference effects of biotin on biotin-mediated Access assays. The Access Total T3 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.

Healthcare facilities and laboratories should stop using the affected assays and contact Beckman Coulter for further instructions. The recall covers all lots of Catalog Number 33830.

The recalled product

Product
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) 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 Diagnostic
Hazard
Affected units
238,862

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: 33830
  • 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 →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · biotin interference

See all →

Similar recalls