Recall Monitor
Health Products

Xpert® CT/NG

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Xpert® CT/NG
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Get told about the next health product recall.

We email or text you when Canada issues a recall that matches what you watch: a brand, a product, an allergen. Most never make the news.

Get health product recall alerts

CA$3.99/mo · cancel anytime

Products

Affected productsLot or serial numberModel or catalogue number
Xpert® CT/NG1001408792GXCT/NG-CE-10
Xpert® CT/NG1001420349GXCT/NG-CE-10
Xpert® CT/NG1001414293GXCT/NG-CE-10
Xpert® CT/NG1001455200GXCT/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.

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime