Device recall
Z-1382-2019: UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465…
FDA device recall · Class I · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1382-2019 |
|---|---|
| Recall event | 82329 |
| Product | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical… |
| Product code | GKZ |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 31, 2022 |
| 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