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.
- Company
- Cepheid
- Recall Initiated
- September 15, 2017
- Terminated
- July 28, 2023
- Recall Number
- Z-0028-2018
- Quantity
- 977 kits (9770 units)
- Firm Location
- Sunnyvale, CA
Reason for Recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
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
Lot / Code Info
batch 1000045409 (lot 06802)
Root Cause
Nonconforming Material/Component
Action Taken
Recall notification letters were sent out to affected consignees on 9/15/17.
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