Beckman Coulter recalls Access Free T3 Triiodothyronine (REF A13422) due to potential biotin interference at high levels, causing assay inaccuracies. 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 Free T3 Triiodothyronine assay (REF A13422) because high levels of biotin in samples can cause inaccurate test results. This affects laboratory use of the device when biotin concentrations exceed 1,200 ng/mL.
The assay can produce inaccurate results if samples contain biotin levels above 1,200 ng/mL. This interference causes a result bias greater than +/-10%, meaning test outcomes may be significantly off.
Laboratories using Beckman Coulter Access Immunoassay Systems with the specific REF A13422 model are affected. Users most at risk are those testing samples with high biotin levels, such as certain biological samples.
Check for the product name 'Access Free T3 Triiodothyronine' with reference number A13422. The device is sold with specific Beckman Coulter systems like Access 2, UniCel DxI 600, and others listed in the recall notice.
Test your samples for biotin content to ensure levels do not exceed 1,200 ng/mL before using the assay.
No, this recall specifically affects the Access Free T3 Triiodothyronine assay (REF A13422) and related tests listed in the notice.
If samples contain biotin levels above 1,200 ng/mL, the assay may produce inaccurate results; check the sample biotin content before testing.
The recall does not provide a fix; users must ensure samples have biotin levels below 1,200 ng/mL 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-2238-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2238-2020 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.
