Device recall
Z-0028-2018: Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse…
FDA device recall · Class II · Cepheid
Key facts
| Recall number (Z-number) | Z-0028-2018 |
|---|---|
| Recall event | 78177 |
| Product | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and… |
| Recalling firm | Cepheid |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2023 |
| FEI number | 3004530258 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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