← All recalls
Medical Device

Access Total T4 Calibrator, Catalog No. 33805

Recall date: 2026-04-29 · Source: FDA_DEVICE
Brand / Firm
Beckman Coulter, Inc.
Product
Access Total T4 Calibrator, Catalog No. 33805
Reason for recall
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.
Units affected
2068 US, 2830 OUS
Description
Access Total T4 Calibrator, Catalog No. 33805
View official recall notice →