Device recall
Z-1007-2010: BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog…
FDA device recall · Class III · BD Biosciences, Systems & Reagents
Key facts
| Recall number (Z-number) | Z-1007-2010 |
|---|---|
| Recall event | 51256 |
| Product | BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument. |
| Product code | GKZ |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 8, 2011 |
| 510(k) numbers | K081213 |
| 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