Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xpert EV Assay Recalled by Cepheid Due to Customers have reported a higher than expected number...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.
Affected Products
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.
Quantity: 977 kits (9770 units)
Why Was This Recalled?
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Where Was This Sold?
USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
About Cepheid
Cepheid has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report