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U.S. Department of Health and Human Services

Class 2 Device Recall Xpert EV Assay, Catalog GXEV100N10.

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  Class 2 Device Recall Xpert EV Assay, Catalog GXEV100N10. see related information
Date Initiated by Firm September 15, 2017
Create Date October 18, 2017
Recall Status1 Terminated 3 on July 28, 2023
Recall Number Z-0028-2018
Recall Event ID 78177
Product Classification unknown device name - Product Code N/A
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.
Code Information batch 1000045409 (lot 06802)
Recalling Firm/
904 E Caribbean Dr
Sunnyvale CA 94089-1189
Manufacturer Reason
for Recall
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
FDA Determined
Cause 2
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

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.