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Terminated

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.

FDA Recall Z-0028-2018 · Posted None

Recalling FirmCepheid
Recall StatusTerminated
Product CodeN/A
Date Initiated2017-09-15
Date Terminated2023-07-28
Product Quantity977 kits (9770 units)

Reason for Recall

Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.

Firm Action

Recall notification letters were sent out to affected consignees on 9/15/17.

Root Cause

Nonconforming Material/Component

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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