Device recall
Z-1945-2016: The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated…
FDA device recall · Class II · Sysmex Corporation
Key facts
| Recall number (Z-number) | Z-1945-2016 |
|---|---|
| Recall event | 70054 |
| Product | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. |
| Product code | GKZ |
| Recalling firm | Sysmex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2016 |
| 510(k) numbers | K112605 |
| FEI number | 3010421384 |
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