Reported Apr 29, 2026 · Ongoing
Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
Access Total T4 CalibratorCatalog No. 33805
- Lot codes and dates
UDI-DI 15099590225872 Lots 538729538815538898539107539243
- Amount recalled
- 2068 US, 2830 OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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