Device recall
Z-2358-2020: BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is…
FDA device recall · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-2358-2020 |
|---|---|
| Recall event | 85129 |
| Product | BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays… |
| 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 | K131301 |
| 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