Recall Z-0028-2018 ยท N/A
Cepheid
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.
| Date | Sep 15, 2017 |
| Status | Terminated |
| Reason | Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. |
| Root cause | Nonconforming Material/Component |
| Action | Recall notification letters were sent out to affected consignees on 9/15/17. |
| Quantity | 977 kits (9770 units) |
| Distribution | USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.