Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication

Date Issued: April 28, 2026

The U.S. Food and Drug Administration (FDA) is alerting consumers and health care providers of risks involved with the use of TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health. Trividia Health has issued a recall that affects all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring Blood Glucose Systems and TRUE METRIX PRO Professional Monitoring Blood Glucose System, including cobranded products sold under store or distribution partner names (collectively referred to as TRUE METRIX in this communication).

The FDA recommends all TRUE METRIX users transition to an alternative method of testing their blood glucose (blood sugar), when possible. 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. 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. Users continuing to use their TRUE METRIX device until they can access an alternative method to test blood glucose should follow the Recommendations for Patients below, including the instructions for what to do if they receive an E-5 Error Code.

The TRUE METRIX recall is for an issue with the software design of the E-5 Error Code and the instructions for the user in the “Messages” section of the Owner’s Booklets/System Instructions for Use and the online labeling and help guides. The TRUE METRIX meters display the same E-5 Error Code for two different types of issues: 1) a very high blood glucose event (> 600 mg/dL), and/or 2) when there is a test strip error. If a user receives an E-5 Error Code when they are having a very high glucose event, they may not seek appropriate treatment if they think it is a test strip error or they may delay appropriate treatment as they try to determine what the error means. Alternatively, if a user assumes the E-5 Error Code is due to a very high blood glucose event, but they actually have low or normal blood glucose, they may improperly treat themselves for high blood glucose when they actually have low or normal blood glucose.  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. As of January 16, 2026, Trividia Health has reported 114 serious injuries and one death associated with this issue.

The FDA is issuing this communication to raise awareness of the manufacturer’s recall, the FDA’s ongoing evaluation with the manufacturer of the issue, and the FDA’s current recommendations.

Recommendations for Patients using TRUE METRIX Meters and their Caregivers

• All TRUE METRIX users should seek an alternative method for testing their blood glucose, if possible, until corrected meters become available. Users should continue testing their blood glucose and should not stop using their TRUE METRIX meter until they have an alternative available for testing. 
  • Users should consult with their health care provider or pharmacist to discuss options for transitioning to an alternative glucose monitoring system. 
  • It is especially important for users at highest risk, such as those who rely on intensive insulin therapy, sulfonylureas, or who have frequent hyper- or hypo- glycemic events, to transition to an alternative glucose monitoring system.
  • Users who continue to use a TRUE METRIX device prior to switching to an alternative method should be aware that an E-5 Error Code may mean that they are having a very high glucose (>600 mg/dL) event or that they have a test strip error, in which case their blood glucose may be normal or may be dangerously low or high. Any user receiving an E-5 Error Code while experiencing symptoms of low or high blood glucose should immediately contact their health care provider for help in determining appropriate treatment options. 
• Be aware that delayed recognition of extremely low or high blood glucose levels could increase the risk of serious health complications or delays in treatment. 
• Report any problems or complications with your TRUE METRIX Meter to the FDA and to Trividia Health.

Recommendations for Health Care Providers

• Immediately notify patients who use affected devices and their caregivers of the updated recommendations for patients using TRUE METRIX meters and assist them in identifying and transitioning to alternative methods of testing their blood glucose. 
• For facilities with multiple patients, post this communication in areas where the products are stored within your facility to notify personnel of the updated recommendations.
• Report any problems or complications your patients experience with TRUE METRIX Meters to the FDA and to Trividia Health.

Device Description

The TRUE METRIX devices are used for the quantitative measurement of glucose (sugar) in fresh whole blood samples. Affected devices may be branded under store or distributor names. The full list of affected products can be found here: Full List of Affected Product

FDA Actions

The FDA identified the February 2026 recall for TRUE METRIX Blood Glucose Monitoring Systems as a Class I recall, the most serious type of recall.

The FDA will continue working with Trividia Health to help ensure that patients, caregivers, and providers are aware of the issue, evaluate information to better understand the issue, and identify additional mitigation strategies as needed.    

The FDA will continue to monitor information about device performance including medical device reports.

The FDA will continue to keep the public informed if significant new information becomes available.

Additional FDA Resources

• Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems [04/28/2026]
• FDA Enforcement Report  
• CDRH Medical Device Recall Database  

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

• Firm Press Release [02/06/2026] 
• Firm-Issued Medical Device Correction Letter [02/06/2026] 
• Firm List of Impacted Products [02/06/2026] 
• Firm Medical Device Web Page

Unique Device Identifier

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label? 
• AccessGUDID database - Identify Your Medical Device 
• Benefits of a UDI System

Reporting Problems with your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).