FDA DevicesClass II
Access Total T4 Calibrator, Catalog No. 33805
Published: April 29, 2026Recall ID: Z-1922-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Access Total T4 Calibrator, Catalog No. 33805
Additional Source Details
| Field | Value |
|---|---|
| City | Chaska |
| State | MN |
| Event id | 98591 |
| Address 1 | 1000 Lake Hazeltine Dr |
| Address 2 | N/A |
| Code info | UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243 |
| Postal code | 55318-1037 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 2068 US, 2830 OUS |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260316 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.