Access Total T4 Calibrator, Catalog No. 33805
FDA device recall Z-1922-2026 · posted 2026-04-22 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Action taken
- Pending
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- KLI
- Quantity affected
- 2068 US, 2830 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Cze
- Date initiated
- 2026-03-16
- Date posted
- 2026-04-22
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS TOTAL T4 ASSAY (K023369) | Beckman Coulter, Inc. | 2002-12-09 |