Access Total T4 Calibrator
Beckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
Stop using affected lots of Access Total T4 Calibrator, Catalog No. 33805, immediately. Contact Beckman Coulter for instructions on replacement calibrators and verification of patient results obtained with affected lots.
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.
How to identify it
UPC 15099590225872
Access Total T4 Calibrator, Catalog No. 33805
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification