Device recall
Z-2357-2020: BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD…
FDA device recall · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-2357-2020 |
|---|---|
| Recall event | 85129 |
| Product | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets… |
| Product code | PER |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2023 |
| 510(k) numbers | K050191 |
| FEI number | 2916837 |
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