Beckman Coulter recalls four lots of Access Total T4 reagent (lots 338555-338958) due to possible imprecision causing inaccurate thyroid test results. Affected units expire by October 2024.
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Beckman Coulter is recalling four specific lots of Access Total T4 reagent for thyroid tests because they may produce inaccurate results. This could lead to incorrect thyroid assessments if used in medical testing.
The reagent lots have imprecision outside the 10% specification, meaning they might give incorrect thyroid test results. This could lead to delayed or wrong diagnoses if used in medical testing.
Healthcare providers using the Access Total T4 reagent for thyroid tests may be affected. Patients receiving tests with these lots could face inaccurate results, but the risk is low.
Check the lot numbers: 338555 (expires July 2024), 338556 (August 2024), 338734 (September 2024), or 338958 (October 2024). The product is used for thyroid tests and expires by October 2024.
Look for lot numbers 338555, 338556, 338734, or 338958 on the reagent packaging.
The reagent lots have imprecision outside the 10% specification, which may result in erroneous or delayed thyroid test results.
Check the lot numbers: 338555 (expires July 2024), 338556 (August 2024), 338734 (September 2024), or 338958 (October 2024).
The recall does not specify a stop-use action, but you should check if your reagent lot is in the recalled list and contact the manufacturer if needed.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1303-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1303-2024 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.
