Device recall
Z-0414-2026: Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158…
FDA device recall · Class II · Cepheid
Key facts
| Recall number (Z-number) | Z-0414-2026 |
|---|---|
| Recall event | 97497 |
| Product | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant… |
| Product code | NQX |
| Recalling firm | Cepheid |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100822, K243070 |
| 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