Device recall
Z-1815-2012: PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per…
FDA device recall · Class III · Tripath Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-1815-2012 |
|---|---|
| Recall event | 61737 |
| Product | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240) |
| Product code | MKQ |
| Recalling firm | Tripath Imaging, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 3, 2012 |
| 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