—#206105

Product

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

FDA product code: KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K023369
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Vendor change control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-02-08
Posted by FDA: 2024-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206105. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.