Drug recall
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain…
FDA recall event 78177 · Class II · Cepheid
Key facts
| Event ID | 78177 |
|---|---|
| Recall numbers | Z-0028-2018 |
| Recalling firm | Cepheid |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. |
| Initiation date | Sep 15, 2017 |
| Report date | Oct 25, 2017 |
| Termination date | Jul 28, 2023 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3004530258 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: