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

