Device recall
Z-1369-2021: Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-1369-2021 |
|---|---|
| Recall event | 87557 |
| Product | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing. |
| Product code | NSU |
| 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