Device recall
Z-1113-2025: Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-1113-2025 |
|---|---|
| Recall event | 96107 |
| Product | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis. |
| Product code | PER |
| Recalling firm | Sysmex America, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3009711478 |
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