Recall Z-1922-2026 · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Beckman Coulter, Inc.
Access Total T4 Calibrator, Catalog No. 33805
| Date | Apr 22, 2026 (initiated Mar 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Pending |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023369 | ACCESS TOTAL T4 ASSAY Beckman Coulter, Inc., Dec 9, 2002 |