Beckman Coulter recalls ACCESS Immunoassay Systems with REF 33860 due to potential biotin interference at high levels, causing assay inaccuracies. Affected units may need testing adjustments.
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, 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 Immunoassay Systems with REF 33860 because high levels of biotin (up to 1,200 ng/mL) can cause inaccurate test results. This affects users who perform thyroid hormone tests or other biotin-dependent assays with the system.
High biotin levels (up to 1,200 ng/mL) in samples can cause significant errors in specific Access assays, leading to inaccurate test results. This interference affects six specific assays, including thyroid hormone tests, by creating a result bias greater than +/-10%.
Users of Beckman Coulter ACCESS Immunoassay Systems with REF 33860, particularly those conducting thyroid hormone tests or biotin-mediated assays. Laboratory staff and healthcare providers using the system are most at risk.
Check for the product REF 33860 (UDI: 15099590227173) on Beckman Coulter ACCESS Immunoassay Systems used with Access 2, UniCel DxI 600, and other compatible systems. All lots of this product are affected.
Test your samples for biotin levels to ensure they do not exceed 1,200 ng/mL before running assays.
Beckman Coulter identified that high biotin levels (up to 1,200 ng/mL) can cause inaccurate test results in specific assays, leading to a result bias greater than +/-10%.
The affected assays include Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898.
No, the recall does not require stopping use. Users should check biotin levels in samples to avoid interference.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2240-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2240-2020 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.
