Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 25, 2017
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.
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cepheid recalled Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcri… - a moderate-severity action.
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcri… was recalled by Cepheid in October 25, 2017. Reason: Customers have reported a higher than expected number of invalid test results when using the recalled product…. Check the official notice for the remedy. Verify recall #Z-0028-2018 with the FDA Devices before acting.
The recall
Cepheid issued this moderate-severity FDA Devices recall-Customers have reported a higher than expected number of invalid test results when using the recalled product….
- Moderate
- severity level
- Class II
- classification
- October 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0028-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0028-2018) was formally reported on October 25, 2017, with the manufacturer initiating the action on September 15, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Cepheid is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 977 kits (9770 units).
The documented reason for this recall is: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. Distribution data in the federal record shows the product reached: USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
977 kits (9770 units)
Related Recalls
6
0 from same agency
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.
Reason for recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0028-2018 |
| Date reported | October 25, 2017 |
| Date initiated | September 15, 2017 |
| Recalling firm | Cepheid |
| Firm location | Sunnyvale, CA |
| Affected scope | 977 kits (9770 units) |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0028-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cepheid. Units affected: 977 kits (9770 units).
Why was this product recalled? ▼
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0028-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0028-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 25, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.