Device recall
Z-2397-2012: BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color…
FDA device recall · Class II · BD Biosciences, Systems & Reagents
Key facts
| Recall number (Z-number) | Z-2397-2012 |
|---|---|
| Recall event | 62494 |
| Product | BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated… |
| Product code | GKZ |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2013 |
| 510(k) numbers | K040026 |
| FEI number | 2916837 |
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