Device recall
Z-2086-2012: PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a…
FDA device recall · Class II · Tripath Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-2086-2012 |
|---|---|
| Recall event | 62117 |
| Product | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other… |
| 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