Device recall
Z-0316-2011: BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences…
FDA device recall · Class II · BD Biosciences, Systems & Reagents
Key facts
| Recall number (Z-number) | Z-0316-2011 |
|---|---|
| Recall event | 55748 |
| Product | BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis. |
| Product code | GKZ |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2011 |
| FEI number | 2916837 |
At a glance
- None 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