# Major Recall Alert: Xpert® CT/NG Test Recalled Due to Rare Genetic Mutation in N. gonorrhoeae Strains
Cepheid, the maker of the Xpert® CT/NG diagnostic test, has issued a major recall after discovering a critical issue linked to a rare genetic mutation event between *Neisseria gonorrhoeae* and *Neisseria meningitidis*. This mutation has caused certain *N. gonorrhoeae* strains to lose the genetic target sites detected by the Xpert® CT/NG test, leading to the possibility of false-negative results. Laboratories and clinics relying on this test for molecular detection of *N. gonorrhoeae* are urged to investigate any discordant results and monitor positivity rates closely.
Read on to learn more about this recall, its importance, and what steps you should take to stay informed and compliant.
---
## Why This Recall is Important
Accurate detection of sexually transmitted infections like *Neisseria gonorrhoeae* (the bacteria that causes gonorrhea) is critical for patient treatment and public health. This recall highlights a rare genetic mutation event that affects test reliability for certain *N. gonorrhoeae* strains.
False-negative results are of particular concern because:
- They can delay patient treatment and increase the risk of complications.
- They may contribute to further spread of the infection.
- Misdiagnosed cases of *N. gonorrhoeae* can lead to adverse health outcomes, including pelvic inflammatory disease, infertility, and a higher risk of HIV transmission.
As this issue directly impacts diagnostic accuracy, all facilities using the Xpert® CT/NG test must take immediate action.
---
### Details of the Recall
Here’s what we know about the Xpert® CT/NG recall:
- **Product Impacted:** Xpert® CT/NG diagnostic test used to detect *N. gonorrhoeae*.
- **Reason for Recall:** A rare genetic mutation between *N. gonorrhoeae* and *N. meningitidis* strains causes *N. gonorrhoeae* to lack the genetic targets detected by the test, leading to potential false-negative results.
- **Date Announced:** October 2023.
- **Manufacturer Recommendation:** Cepheid advises laboratories and clinics to:
- Monitor for decreases in positivity rates.
- Investigate discordant lab results (e.g., cases positive by culture, microscopy, or another nucleic acid amplification test [NAAT] but negative using Xpert® CT/NG).
- Report any identified issues directly to Cepheid.
For official documentation, visit the recall notice [here](https://recalls-rappels.canada.ca/en/alert-recall/xpertr-ctng).
---
### What You Should Do
If your facility uses the Xpert® CT/NG diagnostic test, take the following steps immediately:
1. **Assess Laboratory Results**
- Cross-check previous test results, especially for suspected *N. gonorrhoeae* cases that tested negative.
- Investigate any discrepancies between Xpert® CT/NG test results and other diagnostic methods such as culture or microscopy.
2. **Report Issues Promptly**
- Inform Cepheid of any discordant results or patterns. Use the communication channels provided by the manufacturer.
3. **Educate Staff and Patients**
- Ensure lab technicians, clinicians, and healthcare providers are aware of this recall and its implications.
- Inform patients who may be affected by false negatives and recommend follow-up testing if necessary.
4. **Explore Alternative Testing Options**
- Consider alternative NAATs or diagnostic platforms for the detection of *N. gonorrhoeae* strains during this recall period.
Timely action will help safeguard patient health, prevent misdiagnosis, and maintain trust in diagnostic results.
---
## Stay Safe – Get Instant Recall Alerts
Recalls like this emphasize the importance of staying informed. Protect yourself and your community by downloading our free recall monitoring app. You’ll receive real-time alerts for product recalls like the Xpert® CT/NG test, ensuring compliance and patient safety.
✅ **[Download the App Now](#)** to stay updated on the latest recalls and safety alerts.
For the full details of this recall, consult the official notice [here](https://recalls-rappels.canada.ca/en/alert-recall/xpertr-ctng).
---
Stay proactive, prioritize safety, and ensure diagnostic reliability by responding to this recall promptly. Your healthcare facility’s diligence can help mitigate further risks associated with false diagnostic results.