FDA Recall
Terminated
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.
Recall: Z-0028-2018
·
Initiated September 15, 2017
Recall
- Recall Number
- Z-0028-2018
- Event Number
- 78177
- Firm
- Cepheid
- FEI Number
- 3004530258
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 15, 2017
- Terminated
- July 28, 2023
- Address
- 904 E Caribbean Dr, Sunnyvale, CA, 94089-1189
Description
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.
Action
Recall notification letters were sent out to affected consignees on 9/15/17.
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
Quantity
977 kits (9770 units)