Device recall
Z-0748-2025: FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The…
FDA device recall · Class II · Becton, Dickinson and Company, BD Bio Sciences
Key facts
| Recall number (Z-number) | Z-0748-2025 |
|---|---|
| Recall event | 95729 |
| Product | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a… |
| Product code | OYE |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170974, K201814 |
| FEI number | 3027394506 |
At a glance
- 1–9 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