Public recall detail

Xpert® CT/NG

2025-10-24

medium
Recall Safety notice
Quick summary

Quick summary: Xpert® CT/NG. Date: 2025-10-24.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Xpert® CT/NG. Date: 2025-10-24.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCepheid AB
ProductXpert® CT/NG
IssueMedical devices - Performance
Recall classType II
IdentificationRA-78386

Affected products

ProductXpert® CT/NG
Lot1001408792
ModelGXCT/NG-CE-10
Serial number1001408792
DescriptionXpert® CT/NG
ProductXpert® CT/NG
Lot1001420349
ModelGXCT/NG-CE-10
Serial number1001420349
DescriptionXpert® CT/NG
ProductXpert® CT/NG
Lot1001414293
ModelGXCT/NG-CE-10
Serial number1001414293
DescriptionXpert® CT/NG
ProductXpert® CT/NG
Lot1001455200
ModelGXCT/NG-CE-10
Serial number1001455200
DescriptionXpert® CT/NG

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesCepheid AB Rontgenvagen 5, Solna, Sweden, 17154
Recall date2025-10-13
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78386
Background{}
CompaniesCepheid AB Rontgenvagen 5, Solna, Sweden, 17154
AudiencesHealthcare Industry
Source updated2025-10-24

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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