Cepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results
Cepheid is recalling Xpert EV Assay kits because customers reported a higher than expected number of invalid test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves invalid test results rather than direct physical injury or death, fitting the criteria for moderate severity associated with labeling or performance issues without reported harm.
Plain-English summary
Cepheid is recalling 977 kits (9,770 units) of the Xpert EV Assay, Catalog GXEV-100N-10. The product is a reverse transcription polymerase chain reaction (RT-PCR) assay used with the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid specimens from individuals with signs and symptoms of meningitis.
The recall was initiated because customers reported a higher than expected number of invalid test results when using the product according to the package insert. The affected product is identified by batch 1000045409 (lot 06802).
The recalled product was distributed in the USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, and Uruguay. Users should stop using the affected kits and contact Cepheid for further instructions.
The recalled product
- 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 individual
- Manufacturer
- Cepheid
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- batch 1000045409 (lot 06802)
Distribution
Distribution scope not specified by the agency.
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