Beckman Coulter recalls specific lots of Access TSH reagent packs that may produce erroneously low thyroid-stimulating hormone results. Affected lots include 339117, 338724, 439341, 338367, 338057, 234251.
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Beckman Coulter is recalling certain lots of Access TSH reagent packs that may produce falsely low thyroid-stimulating hormone (TSH) results. This could lead to incorrect diagnoses of thyroid or pituitary disorders if used in medical testing.
The reagent packs may produce erroneously low TSH results, which could lead to incorrect diagnoses of thyroid or pituitary disorders. This happens due to a potential issue with the specific lots of reagent packs.
Healthcare providers using the Access TSH reagent packs for medical testing. Patients receiving thyroid or pituitary disorder diagnoses based on these tests may be affected.
Check the lot numbers on the reagent packs: 339117, 338724, 439341, 338367, 338057, or 234251. The Access TSH (3rd IS) assay is used with the DxI 9000 Access Immunoassay Analyzer.
Verify the lot number on the reagent pack to see if it is one of the affected lots: 339117, 338724, 439341, 338367, 338057, or 234251.
The Access TSH reagent pack is used for measuring thyroid-stimulating hormone (TSH) levels in human serum and plasma to diagnose thyroid or pituitary disorders.
Affected lots include 339117, 338724, 439341, 338367, 338057, and 234251.
No, the recall does not require immediate discontinuation. Affected lots can be identified and checked for use.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0094-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0094-2025 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.
