FDA Class I Recall Highlights Risks With True Metrix Blood Glucose Monitoring Systems

Blood glucose monitoring remains a cornerstone of diabetes management, particularly for patients requiring insulin therapy or intensive glucose control. However, a recent Class I recall issued by the FDA for multiple True Metrix blood glucose monitoring systems is raising concerns about the potential consequences of inaccurate interpretation of glucose readings and device error codes.¹

The recall, which the FDA identified as the most serious type of medical device recall, involves updated use instructions for several Trividia Health glucose monitoring systems due to confusion surrounding the devices’ E-5 error code. The affected products include the True Metrix Self-Monitoring Blood Glucose System, True Metrix Air, True Metrix Go, and True Metrix Pro systems, including certain cobranded versions sold under retailer or distribution partner names.¹

E-5 Error Code Creates Potential for Dangerous Misinterpretation

According to the FDA, the issue stems from the devices displaying the same E-5 error code for 2 different situations: extremely high blood glucose levels exceeding 600 mg/dL and test strip-related errors.¹ This overlap may lead patients to misunderstand the seriousness of their condition or administer inappropriate treatment.

If patients experiencing severe hyperglycemia assume the E-5 code reflects only a strip malfunction, they may delay seeking urgent treatment. Conversely, if patients incorrectly interpret the code as indicating dangerously high glucose when their blood sugar is actually normal or low, they could administer unnecessary insulin or other glucose-lowering interventions.¹

The FDA warned that either scenario may result in severe health complications, including dehydration, altered mental status, loss of consciousness, or death. As of January 16, 2026, Trividia Health reported 114 serious injuries and 1 death associated with the issue.¹

The agency has advised patients, caregivers, pharmacists, and health care professionals to review and follow the updated recommendations included in the FDA Safety Communication issued April 28, 2026.¹

Pharmacists Play Key Role in Diabetes Device Education

Pharmacists are often among the most accessible health care professionals for patients managing diabetes and may be the first to identify confusion surrounding glucose monitoring devices. Counseling patients on proper meter usage, troubleshooting, and error code interpretation is particularly important given the widespread use of self-monitoring blood glucose systems.

Blood glucose meters are commonly used by patients with both type 1 and type 2 diabetes to guide insulin dosing decisions, monitor the effectiveness of medications, and evaluate how lifestyle changes influence glucose levels. Traditional fingerstick meters remain widely utilized because they are relatively affordable, portable, and simple to operate.²

However, the large number of available devices and brand-specific test strips can contribute to patient confusion. Pharmacists frequently assist patients in selecting devices covered by insurance, ensuring compatibility between strips and meters, and counseling on device maintenance and proper testing technique.²

The current recall further underscores the importance of pharmacists proactively educating patients about warning messages and device-specific instructions. Patients experiencing repeated error messages, symptoms of severe hyperglycemia, or unexplained glucose fluctuations should be encouraged to seek medical evaluation promptly.

Growing Importance of Accurate Diabetes Monitoring

Accurate glucose monitoring is essential because treatment decisions are often made in real time based on meter readings. Severe hyperglycemia can rapidly progress to life-threatening complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state if left untreated.³

Although continuous glucose monitoring (CGM) systems have become increasingly popular and can reduce reliance on fingerstick testing, traditional glucose meters remain heavily used across the diabetes population due to cost, insurance coverage, and accessibility considerations. CGM systems also present their own challenges, including sensor adhesion issues and affordability barriers.²

The FDA encouraged health care professionals and consumers experiencing adverse events or quality concerns associated with the affected True Metrix devices to report issues through the MedWatch Safety Information and Adverse Event Reporting Program.¹

REFERENCES

1. Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems. FDA. Published April 28, 2026. Accessed May 15, 2026. 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

2. Najib F. Pros, Cons of Different Diabetes Monitoring Devices, How Pharmacies Can Support Optimal Use. Pharmacy Times. Published January 24, 2022. Accessed May 15, 2026. https://www.pharmacytimes.com/view/pros-cons-of-different-diabetes-monitoring-devices-how-pharmacies-can-support-optimal-use

3. American Diabetes Association Professional Practice Committee for Diabetes* . 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026. Diabetes Care. 2026;49(Supplement_1):S183-S215. doi:10.2337/dc26-S009