Device recall
Z-2088-2012: PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog…
FDA device recall · Class II · Tripath Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-2088-2012 |
|---|---|
| Recall event | 62117 |
| Product | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep… |
| Product code | MKQ |
| Recalling firm | Tripath Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 8, 2013 |
| PMA numbers | P970018 |
| FEI number | 3008007472 |
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