Device recall
Z-1090-2009: BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021…
FDA device recall · Class II · Bd Diagnostic Systems Tripath
Key facts
| Recall number (Z-number) | Z-1090-2009 |
|---|---|
| Recall event | 49548 |
| Product | BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell… |
| Product code | MKQ |
| Recalling firm | Bd Diagnostic Systems Tripath |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2013 |
| PMA numbers | P970018 |
| FEI number | 3004173866 |
At a glance
- None 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