Device recall
Z-1728-2011: Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user…
FDA device recall · Class II · QIAGEN Gaithersburg, Inc.
Key facts
| Recall number (Z-number) | Z-1728-2011 |
|---|---|
| Recall event | 57814 |
| Product | Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to… |
| Product code | JJQ |
| Recalling firm | QIAGEN Gaithersburg, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2011 |
| 510(k) numbers | K980120 |
| FEI number | 3003572099 |
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