FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Recall number
- Z-1303-2024
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Status
- Open, Classified
- Initiated
- 2024-02-08
- Posted
- 2024-03-15
- Terminated
- not on file
- 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. and Canada, complete the attached Replacement Order Form; and (5) For customers outside the U.S. and Canada, contact their local Beckman Coulter representative. The consignee was requested to share the letter information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If the affected product was forwarded to another laboratory, they were requested to provide them a copy of the letter. The consignee was requested to respond within 10 days either electronically via email or manually by completing and returning the enclosed Response Form.
- 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, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.
- Lot, serial or model codes
- Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742.
- 510(k) numbers
- K023369
- PMA numbers
- not on file
- Product code
- KLI
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28