Device recall
Z-1476-2020: QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for…
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-1476-2020 |
|---|---|
| Recall event | 85004 |
| Product | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays. |
| Product code | OOI |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 26, 2024 |
| 510(k) numbers | K113319 |
| 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