Beckman Coulter recalls Access Thyroglobulin Antibody II (TgAb) assays with incorrect instructions that may cause false-low results. Affected units shipped from July 2021 to current. Contact for remedy.
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Beckman Coulter is recalling Access Thyroglobulin Antibody II tests because their instructions incorrectly state that biotin interference has been fixed. This could lead to false-low results in thyroid antibody tests. The recall affects all units shipped from July 2021 onward.
The instructions for use incorrectly state that biotin interference has been resolved. This could cause the test to show lower thyroid antibody levels than actually present, leading to potential misdiagnosis.
Lab technicians and healthcare providers using the Access Thyroglobulin Antibody II tests for thyroid antibody testing. Those who have the specific product model with the listed part numbers are most at risk.
Check for the product name 'Access Thyroglobulin Antibody II' with reference number A32898. The instructions for use (IFU) part numbers B14994, B63978, and A38168 apply to all units shipped from July 2021 to current.
Identify the product name and reference numbers to confirm if your unit is affected.
The test might show false-low results, which could lead to incorrect thyroid antibody levels being reported.
Check for the product name 'Access Thyroglobulin Antibody II' with reference number A32898 and IFU part numbers B14994, B63978, or A38168.
No, the recall does not require immediate discontinuation. However, you should check if your test is affected and contact Beckman Coulter for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0265-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0265-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
