Z-0028-2018Class II

Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain...

Name: Z-0028-2018 Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain...
Creator: Cepheid
Published: 2017-09-15
License: https://open.fda.gov/license/

Cepheid / initiated 2017-09-15 / Terminated / root cause: manufacturing process

FDA source

Cepheid began a recall of 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... on 2017-09-15. FDA classified it as Class II and gives the reason as "Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0028-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2017-10-18
Terminated: 2023-07-28
Recalling firm: Cepheid
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.
Product code: N/A
Reason for recall: Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall notification letters were sent out to affected consignees on 9/15/17.
Quantity in commerce: 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
Product codes and lots: batch 1000045409 (lot 06802)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-18

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)