Device recall
Z-1384-2019: UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product…
FDA device recall · Class I · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1384-2019 |
|---|---|
| Recall event | 82329 |
| Product | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for… |
| 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