Device recall
Z-2034-2017: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1…
FDA device recall · Class II · Sysmex America Inc
Key facts
| Recall number (Z-number) | Z-2034-2017 |
|---|---|
| Recall event | 76828 |
| Product | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan |
| Product code | GKZ |
| Recalling firm | Sysmex America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2019 |
| 510(k) numbers | K112605, K141681 |
| FEI number | 3009711478 |
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