Health product recall

Xpert® CT/NG

Brand(s)
Last updated

Summary

Product
Xpert® CT/NG
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Xpert® CT/NG 1001408792 GXCT/NG-CE-10
Xpert® CT/NG 1001420349 GXCT/NG-CE-10
Xpert® CT/NG 1001414293 GXCT/NG-CE-10
Xpert® CT/NG 1001455200 GXCT/NG-CE-10

Issue

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Cepheid AB

Rontgenvagen 5, Solna, Sweden, 17154

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-78386

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