Xpert® CT/NG recall in Canada: Performance issue
In plain language
This recall involves Xpert® CT/NG medical devices sold in Canada. It's being recalled because a rare genetic mutation can cause false negative results for Neisseria gonorrhoeae. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
- Monitor for decreases in positivity rates.
- Investigate and report discordant laboratory results.
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Affected products
Xpert® CT/NG
Model: GXCT/NG-CE-10
Lot: 1001408792, 1001414293, 1001420349, 1001455200
Why this matters
False negative results for Neisseria gonorrhoeae
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 1001408792, 1001414293, 1001420349, 1001455200
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: GXCT/NG-CE-10
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
False negative results for Neisseria gonorrhoeae
What should consumers do?
Contact the manufacturer if you require additional information. Monitor for decreases in positivity rates. Investigate and report discordant laboratory results.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. False negative results for Neisseria gonorrhoeae
When was this product recalled?
This product was recalled on October 24, 2025.
Is the Cepheid AB brand affected by this recall?
Yes, Cepheid AB products are affected by this recall. This recall involves Xpert® CT/NG medical devices sold in Canada. It's being recalled because a rare genetic mutation can cause false negative results for Neisseria gonorrhoeae. Healthcare professionals should contact the manufacturer for more information.