Reported Sep 30, 2020 · Terminated
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated…
Beckman Coulter Biomedical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Biomedical GmbH · Sauerbruchstr. 50 · Munich, N/A · N/A
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | DxA 5000 | |
B50516 | — | |
| — | 15099590707118 | 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. |
- Lot codes and dates
- Serial/Lot Number(s)/Software Versionall
- Amount recalled
- 32 units
Where it was sold
Why it was 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 .
This product could cause temporary or reversible health problems — stop using it.
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