Device recall
Z-0236-2018: UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0236-2018 |
|---|---|
| Recall event | 78611 |
| Product | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer |
| Product code | GKZ |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2018 |
| 510(k) numbers | K140911 |
| FEI number | 2050012 |
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