FDA Issues Serious Recall for Blood Glucose Meters: What Patients and Providers Need to Know

The U.S. Food and Drug Administration (FDA) has issued a Class I recall — the agency’s most serious recall classification — for certain TRUE METRIX blood glucose meters due to a software malfunction that may display inaccurate error messages during testing.

According to the FDA, affected devices may show an “E-5” error that could be mistaken for a test strip issue instead of indicating extremely high blood sugar levels exceeding 600 mg/dL. This malfunction may lead to delayed treatment, incorrect insulin dosing, or other serious complications for individuals managing diabetes.

Patients using recalled blood glucose monitoring systems are encouraged to contact their healthcare provider or pharmacist to discuss alternative testing options. Healthcare providers should proactively review patient prescriptions and recommend safe replacement devices when appropriate.

Several alternative glucometers and diabetes testing supplies, including the Accu-Chek GUIDE® and Accu-Chek GUIDE ME®, are widely available through pharmacies and health plans.

For additional recall details, visit the official FDA safety notice 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

Manufacturer information regarding the TRUE METRIX recall can be found here: E-5 Product Notice - Trividia Health

Healthcare organizations are also encouraging providers to use digital provider portals for faster authorization requests, claims management, and patient benefit verification.

Staying informed about medical device recalls, diabetes care updates, and FDA safety alerts is essential to protecting patient safety and improving outcomes for those living with chronic conditions.

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