Beckman Coulter recalls ACCESS Immunoassay Systems with potential biotin interference at high levels, affecting thyroid test accuracy. Affected units may give inaccurate results if biotin is present in blood samples.
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 due to a risk of inaccurate thyroid test results when biotin levels in blood samples exceed 1,200 ng/mL. This could lead to incorrect test outcomes if the device is used with high biotin concentrations.
The device can produce inaccurate test results when blood samples contain biotin levels above 1,200 ng/mL. This interference affects specific thyroid-related tests, potentially leading to incorrect diagnoses if the device is used without proper biotin management.
Users of Beckman Coulter ACCESS Immunoassay Systems, particularly those performing thyroid tests with high biotin levels in their blood samples. Laboratory personnel and healthcare providers using these systems are most at risk.
Check for the product name 'Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II' with catalog number A32898 and unique device identifier 15099590202910. These units were sold with the Access 2, UniCel DxI 600, and other Access Family systems.
Verify if your blood sample contains biotin levels above 1,200 ng/mL before using the device for thyroid tests.
Beckman Coulter identified that high biotin levels in blood samples (up to 1,200 ng/mL) can cause inaccurate results in specific thyroid tests using these devices.
The affected tests include Free T3, Total T3, Free T4, GI Mon, Tg, and TgAbII tests when biotin levels exceed 1,200 ng/mL.
No, the recall does not require stopping use. Users should check biotin levels in blood samples before 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-2242-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2242-2020 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.
