Access Total T4, REF 33800, IVD, thyroxine reagent assay recallZ-1303-2024 · Beckman Coulter, Inc. · initiated Feb 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Vendor change control
What the company is doing
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.
Recall details
- Recall number
- Z-1303-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 8, 2024
- Posted by the FDA
- Mar 15, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 64,009 kits
- Product code
- KLI
- FDA submissions
- K023369
- 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.
Product description
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access Total T4 33800Beckman Coulter, Inc. · Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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