Device recall
Z-0453-2012: Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog…
FDA device recall · Class III · Cepheid
Key facts
| Recall number (Z-number) | Z-0453-2012 |
|---|---|
| Recall event | 60481 |
| Product | Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; |
| Product code | NQX |
| Recalling firm | Cepheid |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 9, 2012 |
| 510(k) numbers | K082140, K101879 |
| 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