fda_recall · device_recall · high

Beckman Coulter, Inc. — Class II recall: Access Total T4 Calibrator, Catalog No. 33805

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:52:55Z
Source ID
Z-1922-2026
Payload hash
281e502a6d81b570a755de42

Summary

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 treat… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.