Device recall
Z-0009-2025: BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD…
FDA device recall · Class II · Becton, Dickinson and Company, BD Bio Sciences
Key facts
| Recall number (Z-number) | Z-0009-2025 |
|---|---|
| Recall event | 95215 |
| Product | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. |
| Product code | PER |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3027394506 |
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