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

FDA device recall Z-1303-2024 · posted 2024-03-15 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

Action taken

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.

Root cause

Vendor change control

Status

Open, Classified

Product code

KLI

Quantity affected

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, G

Date initiated

2024-02-08

Date posted

2024-03-15

Location

Chaska, MN

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