FDA issues Class I recall for True Metrix

The U.S. Food and Drug Administration has classified a recall involving Trividia Health’s TRUE METRIX blood glucose monitoring systems as Class I, the agency’s highest-risk category, after warning that an error code can be misread during dangerously high blood sugar events. The FDA said on April 28 that the affected products include all TRUE METRIX, TRUE METRIX AIR and TRUE METRIX GO self-monitoring systems, as well as TRUE METRIX PRO professional systems, including co-branded versions sold under store or distribution partner names. The issue centers on the devices’ E-5 error code and the instructions that explain it, according to the FDA and Trividia. The agency said misuse or delayed treatment could lead to serious injury or death. ### Which TRUE METRIX products are covered? The FDA said the action covers all four main TRUE METRIX product lines and co-branded products sold under partner labels. The recall database lists four Class I recall entries tied to the same event, covering owner’s booklets and instructions for use associated with the self-monitoring, AIR, GO and PRO versions. The recall entries were posted on March 12, 2026, and remain open in the FDA database. (fda.gov) Trividia announced the correction on February 6, 2026, saying the labeling change applied to products distributed in the United States, United Kingdom, Mexico, Australia and the Caribbean. The company described the action as a modification to the owner’s booklets, system instructions for use, online labeling and help guides. (fda.gov) ### What is wrong with the E-5 error code? The FDA said TRUE METRIX meters use the same E-5 error code for two different situations: a very high blood glucose event above 600 mg/dL, or a test strip error. That overlap can cause a user to mistake a medical emergency for a strip problem, or to assume they have severe hyperglycemia when they do not. (fda.gov) Trividia said the existing instructions did not sufficiently emphasize that users who receive an E-5 error while experiencing symptoms of high glucose should seek medical attention immediately. The company said delayed treatment could cause serious adverse health consequences or death, especially for users with very high blood glucose levels. (fda.gov) ### How many injuries have been reported? Trividia said that since the global launch of TRUE METRIX in August 2014, there have been 114 reported serious injuries and one death associated with the E-5 error code. The company disclosed that figure in its February 6 recall notice posted by the FDA. (fda.gov) The FDA’s April 28 recall update said the device may cause serious injury or death if users do not follow the agency’s recommendations. The agency did not list a new injury total in the recall update viewed for this report. ### What are patients and clinicians being told to do now? (fda.gov) The FDA said patients, caregivers and health care providers should follow the recommendations in its April 28, 2026 safety communication on risks tied to TRUE METRIX systems. The agency said those recommendations include updated guidance for responding to the E-5 error code. (fda.gov) Trividia said users who see an E-5 error should retest with a new strip and seek medical attention immediately if the error persists and they have symptoms such as fatigue, excess urination, thirst or blurry vision. The company also said users without symptoms should retest and contact customer support if the error continues. (fda.gov) ### Where can users find the recall details? The FDA recall database lists the event under Recall Event ID 98317 and includes four Class I recall numbers: Z-1545-2026, Z-1546-2026, Z-1547-2026 and Z-1548-2026. The agency’s recall page links to the affected product information and to its separate safety communication. Trividia said eligible patients may request a free replacement TRUENESS blood glucose monitoring system, including a meter and test strips, through customer support. (fda.gov) The company’s update said users can call 1-888-943-2387, Monday through Friday, 8 a.m. to 8 p.m. Eastern time, to sign up to be contacted about a replacement meter. (amerihealthcaritasnext.com) (accessdata.fda.gov)