Cepheid Xpert EV Assay Recall: Invalid Test Results
Cepheid recalls Xpert EV Assay (GXEV-100N-10) due to higher than expected invalid test results in CSF samples for meningitis diagnosis.
Lower-risk recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Contact the company
What happened, in plain English
Cepheid is recalling Xpert EV Assay (GXEV-10:100N-10) because users report more invalid test results than expected. This could lead to inaccurate diagnoses of meningitis in patients with suspected enterovirus infections. Read more at govinfonow.com/recall/73017-cepheid-xpert-ev-assay-recall-invalid-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/73017-cepheid-xpert-ev-assay-recall-invalid-test-results · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0028-2018
Cite this page
“Cepheid Xpert EV Assay Recall: Invalid Test Results.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73017-cepheid-xpert-ev-assay-recall-invalid-test-results. Based on FDA recall #Z-0028-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2018%22&limit=1).
Why it’s dangerous
The assay produces more invalid test results than expected, which could lead to incorrect diagnoses of enterovirus infections in cerebrospinal fluid samples. This may cause unnecessary treatments or missed diagnoses of meningitis.
Who’s affected
Healthcare providers using the Xpert EV Assay for meningitis testing are most affected. Patients with suspected meningitis who receive this test may have inaccurate results.
How to tell if you have this one
Check for the Xpert EV Assay with catalog number GXEV-100N-10. The affected batch is 1000045409 (lot 06802).
- Brand
Cepheid- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number and batch number to confirm if your Xpert EV Assay is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 5.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0028-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0028-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.