Urgent Correction Issued for TRUE METRIX Instructions

On Feb. 6, 2026, Trividia Health initiated an Urgent Medical Device Correction for TRUE METRIX® Blood Glucose Monitoring Systems (including TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO®). The Center for Devices and Radiological Health (CDRH) at the FDA also issued an Early Alert to notify the public of a potential high-risk device issue. The correction was prompted by inadequately emphasized instructions regarding the E-5 error code, which can indicate very high blood glucose levels (>600mg/dL) or a test strip error and could potentially lead to delays in seeking medical care. Reported medically significant outcomes associated with this issue include 114 serious injuries and one death, attributed to delayed treatment of severe hyperglycemia. The TRUE METRIX Blood Glucose Monitoring Systems are FDA cleared medical devices intended for the self-monitoring or professional monitoring of blood glucose levels in individuals with diabetes. The affected products include TRUE METRIX systems as well as multiple private label and co branded versions distributed through retail pharmacies, grocery chains and other distributors. For updated instructions and to read more about the correction, see here.