Xpert EV Assay — Class II medical device recall Z-0028-2018
Terminated recall by Cepheid, reported 2017-10-25. Customers have reported a higher than expected number of invalid test results when using the recalled product
| Recall number | Z-0028-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-10-18 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2023-07-28 |
| Countries outside the US | AT, AU, BE, BR, CA, CL, CO, DE, ES, FR, GB, IE, IL, IT, KR, LB, NL, PH, SA, SE, UY |
| Lot numbers | 06802, 1000045409 |
| Model numbers | GXEV-100N-10 |
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 symptoms of meningitis.
Reason for recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0028-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.