Device recall
Z-1898-2010: Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System…
FDA device recall · Class I · Cepheid
Key facts
| Recall number (Z-number) | Z-1898-2010 |
|---|---|
| Recall event | 55670 |
| Product | Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient… |
| Product code | NQX |
| Recalling firm | Cepheid |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 25, 2011 |
| 510(k) numbers | K082140 |
| 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