The Recall Desk
HighFDA (Devices)·Z-2242-2020·Announced 2020-06-10

Beckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference

Beckman Coulter is recalling Access Thyroglobulin Antibody II assays because biotin can cause significant result bias.

What this means for you

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 is classified as FDA Class II, and the hazard involves significant test result bias due to biotin interference, which poses a risk of harm through misdiagnosis or treatment errors, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Beckman Coulter Inc. is recalling the Access Thyroglobulin Antibody II (REF A32898) immunoassay system. The recall involves 123,324 units distributed across the United States, US territories, and numerous international locations. The product is used with the Access Family of Immunoassay Systems, including the Access 2, UniCel DxI 600, and various UniCel DxC models.

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

Healthcare facilities and laboratories using these systems should stop using the affected product and contact Beckman Coulter for further instructions. The recall covers all lots of Catalog Number A32898.

The recalled product

Product
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) 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 D
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
123,324

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: A32898
  • 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.

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Same hazard · biotin interference

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