Beckman Coulter recalls Access Total T4 Calibrator (Catalog No. 33805) with negative bias causing false low patient results. This may lead to unnecessary tests, delayed hyperthyroidism treatment, or incorrect dosing for pregnant patients.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Beckman Coulter is recalling Access Total T4 Calibrator models with Catalog No. 33805 due to a negative bias that can cause false low patient results. This risk may lead to unnecessary diagnostic tests, delayed treatment for hyperthyroidism, or incorrect medication dosing for pregnant patients.
The calibrator has a negative bias that causes test results to be falsely low. This could lead to patients being treated for conditions they don't have or receiving delayed treatment for hyperthyroidism. For pregnant patients, incorrect dosing of thyroid hormone could cause treatment issues.
Patients using the Access Total T4 Calibrator for thyroid hormone testing, especially those with hyperthyroidism or pregnant patients receiving thyroid hormone supplementation, are most at risk.
Check for the calibrator model with Catalog No. 33805. The affected lots are 538729, 538815, 538898, 539107, and 539243. This product was sold with UDI-DI 15099590225872.
Identify the model number and lot numbers to confirm if your calibrator is affected.
False low patient results could cause unnecessary additional tests, delayed treatment for hyperthyroidism, or incorrect medication dosing for pregnant patients.
Check for Catalog No. 33805 and affected lots: 538729, 538815, 538898, 539107, or 539243.
The recall does not specify a stop-use action; you should check if your calibrator is affected before taking action.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1922-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1922-2026 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.
