Cepheid: Medical Device Recall in 2017 - (Recall #: Z-0028-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 15, 2017

Date Posted: October 25, 2017

Recall Number: Z-0028-2018

Event ID: 78177

Reason for Recall:

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

Status: Terminated

Product Quantity: 977 kits (9770 units)

Code Information:

batch 1000045409 (lot 06802)

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

Voluntary or Mandated:

Voluntary: Firm initiated