CLASS II Device recall · Reported 25 Oct 2017 · FDA Enforcement Report
Xpert EV Assay recalled by Cepheid
Cepheid is recalling Xpert EV Assay. The recall was initiated on 15 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0028-2018
- FDA event ID
- 78177
- Recalling firm
- Cepheid, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2017
- FDA classified
- 18 Oct 2017
- Reported
- 25 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 15 Sep 2017 | Recall initiated by company | |
| 18 Oct 2017 | Classified by FDA | +33 days |
| 25 Oct 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
Questions about this recall
Why was it recalled?
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Which lots are affected?
batch 1000045409 (lot 06802)
Where was it 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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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