Recall Z-1922-2026
Beckman Coulter, Inc. · initiated March 16, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access Total T4 Calibrator, Catalog No. 33805
Codes / lots: UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Pending
Details
- Recall number
- Z-1922-2026
- Initiated
- March 16, 2026
- Posted by FDA
- April 22, 2026
- Product code
- KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Quantity
- 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, 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…
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN