Cepheid recalls Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction

Recalled October 25, 2017 · FDA recall Z-0028-2018 · Cepheid

Hazard

Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. · FDA Class II

Units

977 kits (9770 units)

Sold at

USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay

Description

Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.

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.

Manufacturer(s)

Cepheid

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →