Reported Oct 25, 2017 · Terminated
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction…
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- 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.
- Lot codes and dates
- batch 1000045409 (lot 06802)
- Amount recalled
- 977 kits (9770 units)
Why it was recalled
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
This product could cause temporary or reversible health problems — stop using it.
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