Find Alternative to Glucometer Linked With 114 Injuries, FDA Says

Patients using recalled True Metrix blood glucose monitoring systems linked to one death and over 100 serious injuries should switch to an alternative testing method when possible, the FDA said on Tuesday.

In a safety communication, the agency warned that a software problem with Trividia Health’s True Metrix blood glucose meters may lead to improper treatment. As of Jan. 16, one death and 114 serious injuries have been linked to the issue. The FDA in February designated the recall as class I — the most serious type.

“Users should continue testing their blood glucose and should not stop using their True Metrix meter until they have an alternative method available for testing,” the FDA advised. “It is especially important for those users at highest risk, including those who are on intensive insulin therapy, sulfonylureas, or who have frequent hyper- and hypo-glycemic events, to transition to an alternative glucose monitoring system.”

Healthcare providers should notify patients using affected devices, the agency said.

The recall includes Trividia’s True Metrix, True Metrix Air, and True Metrix Go self-monitoring blood glucose systems, as well as the True Metrix Pro professional monitoring blood glucose system. It also extends to co-branded products sold under various store or distribution partner names. The systems are designed to help manage type 1 and type 2 diabetes.

A software design problem regarding the E-5 Error Code prompted the recall. Meters display the same error code for two very different types of issues: a blood glucose over 600 mg/dL, and test strip errors.

If patients receive an E-5 Error Code during a dangerously high glucose event, they may fail to seek appropriate treatment if they believe it was due to a test strip error. Conversely, if the code is due to a test strip error, patients may mistakenly treat themselves for hyperglycemia when their blood sugar is actually normal or low.

“Either a delay in treatment or improper treatment may result in serious adverse health consequences, such as dehydration, altered mental status, loss of consciousness, or death, especially for users with very high or very low blood glucose levels,” the FDA noted.

Healthcare professionals are urged to report any complications to both the FDA and Trividia Health.

Trividia is not the first company to face issues with glucose monitors. In 2025, Abbott issued a correction after tests revealed some of its glucose sensors gave false low readings that were potentially associated with hundreds of adverse events and seven deaths worldwide.