Device recall
Z-2548-2016: Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA…
FDA device recall · Class II · Cepheid
Key facts
| Recall number (Z-number) | Z-2548-2016 |
|---|---|
| Recall event | 74803 |
| Product | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for… |
| Product code | NQX |
| Recalling firm | Cepheid |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2016 |
| 510(k) numbers | K070462 |
| 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