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May 5, 2026
On April 28, 2026, the Food and Drug Administration (FDA) issued a safety communication about risks associated with TRUE METRIX Blood Glucose Monitoring Systems (Trividia Health), devices used by patients with diabetes to avoid over- or underuse of insulin or other medications that alter glucose metabolism.[1] Confusing error messages from these devices have led to serious injuries. As of Jan. 16, 2026, Trividia Health had reported 114 serious injuries and one death.
The FDA recommends that anyone using TRUE METRIX devices for glucose monitoring—especially those on insulin or sulfonylureas—switch to alternative monitoring devices. Persons at heightened risk include those who often experience hypo- and hyperglycemic events. A pharmacist or other medical provider can help identify alternatives.
Until an alternative method to test blood glucose is available, the FDA recommends continued use of the TRUE METRIX device, with patient awareness that an “E-5” error code may indicate very high glucose (>600 mg/dL) or a glucose test strip error, “in which case their blood glucose may be normal or may be dangerously low or high.”
Early signs of hyperglycemia include increased thirst or hunger, frequent urination, headache and blurred vision.[2] Signs of hypoglycemia include paleness, shakiness, sweating, headache, hunger or nausea, irregular heartbeat, fatigue, irritability, difficulty concentrating, lightheadedness and numbness around the mouth.[3] Such symptom clusters should not be ignored, even if they appear inconsistent with the TRUE METRIX reading.
The April 2026 FDA recommendation to transition from the TRUE METRIX to another glucose monitoring system follows a February 2026 warning about the potentially confusing error message.[4] The earlier warning recommended retesting. The FDA now recommends switching to an alternative method of testing blood glucose.
The specific devices included in the recall are: TRUE METRIX, TRUE METRIX AIR and GO Self-Monitoring Blood Glucose Systems, the TRUE METRIX PRO Professional Monitoring Blood Glucose System and many co-branded products sold under the names of stores or distributors. A full list, with product numbers, can be found at: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/blood-glucose-monitor-recall-trividia-health-issues-correction-true-metrix-blood-glucose-monitoring.
Public Citizen’s Health Research Group fully supports the FDA’s recommendations. Consumers should promptly determine if they are using TRUE METRIX Blood Glucose Monitoring Systems. Clinicians should immediately notify patients who use the affected devices and their caregivers of the updated recommendations and help them to switch to other methods of testing their blood glucose.
To see the FDA’s safety communication, visit the following link: https://www.fda.gov/medical-devices/safety-communications/risks-using-true-metrix-blood-glucose-monitoring-systems-trividia-health-fda-safety-communication.
Problems or complications with the TRUE METRIX devices should be reported to the FDA and Trividia Heatlh.
References
[1] U.S. Food and Drug Administration. Risks of using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication. April 28, 2026. https://www.fda.gov/medical-devices/safety-communications/risks-using-true-metrix-blood-glucose-monitoring-systems-trividia-health-fda-safety-communication. Accessed May 1, 2026.
[2] Cleveland Clinic. Hyperglycemia (High Blood Sugar). March 2, 2023. https://my.clevelandclinic.org/health/diseases/9815-hyperglycemia-high-blood-sugar. Accessed May 1, 2026.
[3] Mayo Clinic. Hypoglycemia. November 18, 2023. https://www.mayoclinic.org/diseases-conditions/hypoglycemia/symptoms-causes/syc-20373685. Accessed May 1, 2026.
[4] U.S. Food and Drug Administration. Early alert: Trividia health issues correction for TRUE METRIX blood glucose monitoring systems. February 17, 2026. https://web.archive.org/web/20260310130411/https:/www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-trividia-health-issues-correction-true-metrix-blood-glucose-monitoring-systems. Accessed May 1, 2026.
