# FDA recall Z-0028-2018

> **Cepheid** · Class II · device recall initiated 2017-09-15.

## 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 individuals with signs and symptoms of meningitis.

## Reason for recall

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

## Distribution

USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay

## Key facts

- **Recall number:** Z-0028-2018
- **Recalling firm:** Cepheid
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2017-10-25
- **Termination date:** 2023-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2018

## Citation

> AI Analytics. FDA recall Z-0028-2018. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0028-2018. Source: US FDA. Licensed CC0.

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