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An official Health Canada notice concerns Xpert® ct ng. Cepheid has become aware of a rare genetic mutation event between Neisseria gonorrhoeae and Neisseria meningitidis that caused some Neisseria gonorrhoeae strains to lack target sites for the Cepheid Xpert® CT/NG test, leading to false negative results. Cepheid recommends that laboratories and clinics using the Xpert® CT/NG test as their molecular method for the detection of N. Gonorrhoeae monitor for decreases in the positivity rate and ensure that discordant laboratory results (e.g. Testing negative on the Xpert® CT/NG test but positive for NG by culture/microscopy or testing negative on Xpert® CT/NG test but positive for NG using another NAAT) be investigated further and reported to cepheid. Published 2025-10-24.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78386
Official notice
2025-10-24
The hazard
The hazard
Cepheid has become aware of a rare genetic mutation event between Neisseria gonorrhoeae and Neisseria meningitidis that caused some Neisseria gonorrhoeae strains to lack target sites for the Cepheid Xpert® CT/NG test, leading to false negative results. Cepheid recommends that laboratories and clinics using the Xpert® CT/NG test as their molecular method for the detection of N. Gonorrhoeae monitor for decreases in the positivity rate and ensure that discordant laboratory results (e.g. Testing negative on the Xpert® CT/NG test but positive for NG by culture/microscopy or testing negative on Xpert® CT/NG test but positive for NG using another NAAT) be investigated further and reported to cepheid.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Cepheid, Xpert® Ct Ng.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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