Recall Z-0028-2018— Cepheid
Class II · Terminated
Class II FDA medical device recall by Cepheid, initiated 2017-09-15, terminated 2023-07-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert..
- Recalling firm
- Cepheid
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-15
- Terminated
- 2023-07-28
- Firm location
- Sunnyvale, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.