Beckman Coulter recalls ACCESS Immunoassay Systems that may show inaccurate results if biotin levels exceed 1,200 ng/mL, affecting specific cancer and thyroid tests.
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Beckman Coulter is recalling certain ACCESS Immunoassay Systems that may give incorrect results when biotin levels in the sample exceed 1,200 ng/mL. This could lead to inaccurate cancer antigen 19-9 and thyroid tests if the biotin interference is not accounted for.
The system may produce results that are off by more than 10% when biotin levels reach 1,200 ng/mL. This interference affects specific tests for cancer antigen 19-9 and thyroid hormones, potentially leading to incorrect medical conclusions.
Users of Beckman Coulter ACCESS Immunoassay Systems with the specific model REF 387687 are affected. Laboratory personnel and patients using these systems for cancer and thyroid tests are most at risk of inaccurate results.
Check for the model number REF 387687 on the ACCESS Immunoassay System. The product was sold with the unique device identifier (UDI) 15099590231842 and includes specific laboratory systems like the Access 2 and UniCel DxI 800.
Verify if your sample contains biotin levels above 1,200 ng/mL, which could cause inaccurate test results.
The recall affects specific tests: Free T3, Total T3, Free T4, GI Monitor Cancer Antigen 19-9, Tg, and TgAbII.
If your test results show a bias greater than 10% compared to the expected values, it may be affected by biotin interference.
No, but you should check for biotin levels in your samples before using the system for testing.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2241-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2241-2020 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.
