Access Total T4 Calibrator, Catalog No. 33805
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 16, 2026 |
| Reported | April 29, 2026 |
| Recalling firm | Beckman Coulter, Inc. |
| Country / region | United States MN |
Hazard
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.
Affected products
- Access Total T4 Calibrator, Catalog No. 33805
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