Recall Z-1303-2024 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Beckman Coulter, Inc.
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
| Date | Mar 15, 2024 (initiated Feb 8, 2024) |
| Status | Open, Classified |
| Reason | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| Root cause | Vendor change control |
| Action | The recalling firm issued letters on 2/8/2024 via email and standard postal mail to their U.S. customers and postal mail to their OUS customers. The letter explained the issue, impact, and actions to be taken. The actions included: (1) Discontinue using the affected lots and discard all remaining reagent packs from the lots; (2) The firm recommended performing a retrospective review on patient results generated with the affected reagent lots and assess the need for retesting;(3) Contact the local Beckman Coulter representative for replacement product requests; (4) For customers in the U.S. a |
| Quantity | 64,009 kits |
| Distribution | Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023369 | ACCESS TOTAL T4 ASSAY Beckman Coulter, Inc., Dec 9, 2002 |