Device recall
Z-1717-2020: Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-1717-2020 |
|---|---|
| Recall event | 84759 |
| Product | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. |
| Product code | KQO |
| Recalling firm | Sysmex America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2023 |
| FEI number | 1000515253 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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