Device recall
Z-0782-2024: PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-0782-2024 |
|---|---|
| Recall event | 93593 |
| Product | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully… |
| Product code | OOI |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2024800 |
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