CanadaCepheid AB’s Xpert® CT/NG molecular test (model GXCT/NG-CE-10) with lot/serial numbers 1001408792, 1001420349, 1001414293 and 1001455200 is affected. A rare genetic mutation event between Neisseria gonorrhoeae and Neisseria meningitidis can cause some N. gonorrhoeae strains to lack target sites for the test, producing false negative results. Laboratories and clinics should monitor for decreases in positivity, investigate discordant results and report them to Cepheid, and contact the manufacturer for additional information.
What's being recalled
Companies: Cepheid AB, Rontgenvagen 5, Solna, Sweden, 17154.
How to identify it
Affected products: Xpert® CT/NG; Lot or serial number: 1001408792; Model or catalogue number: GXCT/NG-CE-10
Affected products: Xpert® CT/NG; Lot or serial number: 1001420349; Model or catalogue number: GXCT/NG-CE-10
Affected products: Xpert® CT/NG; Lot or serial number: 1001414293; Model or catalogue number: GXCT/NG-CE-10
Affected products: Xpert® CT/NG; Lot or serial number: 1001455200; Model or catalogue number: GXCT/NG-CE-10
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)