Beckman Coulter recalls ACCESS Total T3 Triiodothyronine assays (REF 33830) due to potential biotin interference at high levels, causing inaccurate results. Affected units include specific models and lots.
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 its ACCESS Total T3 Triiodothyronine assays (REF 33830) because high levels of biotin in samples can cause inaccurate test results. This affects laboratory use of these specific assays with certain equipment.
The assays can produce inaccurate results when samples contain up to 1,200 ng/mL of biotin, which is a common substance in some lab samples. This interference causes a result bias greater than +/-10% for specific tests.
Laboratories using Beckman Coulter ACCESS Total T3 Triiodothyronine assays (REF 33830) with specified equipment models are affected. Those handling samples with high biotin levels may see inaccurate results.
Check for the product name 'Beckman Coulter ACCESS Total T3 Triiodothyronine' with catalog number 33830. The recall covers all lots of this product used with specified Beckman Coulter equipment models.
Test your samples for biotin content before running the assay to avoid inaccurate results.
No, the recall does not require stopping use. Labs can continue using the assays but should check for high biotin levels in samples.
The recall affects Beckman Coulter ACCESS 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
Samples with biotin levels up to 1,200 ng/mL may cause inaccurate results; check with your lab's biotin testing procedures.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2239-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2239-2020 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.
