Device recall
Z-0027-2018: Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-0027-2018 |
|---|---|
| Recall event | 78216 |
| Product | Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use |
| Product code | NSU |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 30, 2020 |
| 510(k) numbers | K132251 |
| FEI number | 2024800 |
At a glance
- 1–9 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