Device recall
Z-1039-04: Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard…
FDA device recall · Class II · Digene Corp
Key facts
| Recall number (Z-number) | Z-1039-04 |
|---|---|
| Recall event | 29292 |
| Product | Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003. |
| Product code | LSO |
| Recalling firm | Digene Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 23, 2004 |
| FEI number | 3003572099 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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