Device recall
Z-2163-2020: Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-2163-2020 |
|---|---|
| Recall event | 85346 |
| Product | Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214 |
| Product code | OCC |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171963 |
| 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