Device recall
Z-1636-2012: BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. The BD Focal…
FDA device recall · Class III · Tripath Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-1636-2012 |
|---|---|
| Recall event | 61444 |
| Product | BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide. |
| Product code | MKQ |
| Recalling firm | Tripath Imaging, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 3, 2012 |
| PMA numbers | P970009 |
| FEI number | 3008007472 |
At a glance
- None Linked 510(k)s
- 10–99 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