Device recall
Z-2983-2020: DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA…
FDA device recall · Class II · Beckman Coulter Biomedical GmbH
Key facts
| Recall number (Z-number) | Z-2983-2020 |
|---|---|
| Recall event | 85874 |
| Product | 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… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2022 |
| 510(k) numbers | K190298 |
| FEI number | 3006677029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database