Device recall
Z-1651-2010: Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale…
FDA device recall · Class III · Cepheid
Key facts
| Recall number (Z-number) | Z-1651-2010 |
|---|---|
| Recall event | 55079 |
| Product | Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. |
| Product code | OPU |
| Recalling firm | Cepheid |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 23, 2011 |
| FEI number | 3004530258 |
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