Device recall
Z-2401-2011: Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software…
FDA device recall · Class II · Cepheid
Key facts
| Recall number (Z-number) | Z-2401-2011 |
|---|---|
| Recall event | 58568 |
| Product | Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48 |
| Product code | NJR |
| Recalling firm | Cepheid |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2011 |
| 510(k) numbers | K103766 |
| FEI number | 3004530258 |
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