Official recall record

Xpert® CT/NG

What the authority reported

Cepheid has become aware of a rare genetic mutation event between N eisseria gonorrhoeae and N eisseria meningitidis that caused some N eisseria 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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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