Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DxA 5000 Recalled by Beckman Coulter Biomedical GmbH Due to The DxA 5000 instructions for use may be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Biomedical GmbH directly.
Affected Products
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
Quantity: 32 units
Why Was This Recalled?
The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Biomedical GmbH
Beckman Coulter Biomedical GmbH has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report