FDA-Device2017-10-25Class II
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.
Cepheid
Hazard
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Sold states
USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
Affected count
977 kits (9770 units)
Manufactured in
904 E Caribbean Dr, Sunnyvale, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2018Don't want to check this manually?
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