Beckman Coulter recalls Access Free T4 Thyroxine kits that may show inaccurate results if biotin levels exceed 1,200 ng/mL, affecting lab tests for thyroid hormones.
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 Access Free T4 Thyroxine test kits because high levels of biotin in the blood can cause inaccurate lab results for thyroid tests. This affects specific test kits used with certain medical devices.
The test kits can give wrong results when blood samples contain biotin levels above 1,200 ng/mL. This interference affects specific thyroid hormone tests and may lead to incorrect diagnoses.
People using Beckman Coulter Access Free T4 Thyroxine test kits with specific medical devices may get inaccurate thyroid test results if they have high biotin levels in their blood. Those with high biotin levels are most at risk.
Check for the product name 'Beckman Coulter Access Free T4 Thyroxine' with catalog number 33880. The kits are sold with specific medical devices like Access 2, UniCel DxI 600, and other Beckman Coulter systems.
If you have high biotin levels in your blood, contact your healthcare provider for testing.
Confirm the product name and catalog number to ensure you have the recalled kit.
The test kits may show inaccurate results if blood samples contain biotin levels above 1,200 ng/mL, which can affect thyroid hormone tests.
No, you can continue using the kit if your biotin levels are below 1,200 ng/mL. Contact your healthcare provider if you have high biotin levels.
The recalled product is 'Beckman Coulter Access Free T4 Thyroxine' with catalog number 33880, sold with specific medical devices like Access 2 or UniCel DxI 600 systems.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2237-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2237-2020 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.
