FDA Device recall Z-0028-2018
Xpert EV Assay, Catalog GXEV-100N-10
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Xpert EV Assay, Catalog GXEV-100N-10 by Cepheid, citing customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0028-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-15 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cepheid |
| Distribution | n/a |
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
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Identifiers
| code_info | batch 1000045409 (lot 06802) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cepheid
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid - Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
FDA Device · Class II · 2025-12-03 · Cepheid - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid - Cepheid, Sample Collection Device, Part: 900-0370
FDA Device · Class II · 2024-08-21 · Cepheid
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.