Z-0028-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- July 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 977 kits (9770 units)
Product 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 for Recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Distribution Pattern
USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
Code Information
batch 1000045409 (lot 06802)