Blood Glucose Monitoring Systems

  • As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.
  • Company: Trividia Health, Inc.
  • Medical Devices
  • FDA
  • May 1, 2026

Product details

  • Blood Glucose Monitoring Systems

Company announcement

Trividia Health, Inc. is updating the labeling for TRUE METRIX Blood Glucose Monitoring Systems due to an issue with the E-5 Error Code.

Users are advised to transition to an alternative method of testing their blood glucose or follow the updated instructions if they receive an E-5 Error Code.

The updated notice affects all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO branded Blood Glucose Meters distributed in the United States.

Risk:

Delayed recognition of extremely low or extremely high blood glucose levels could increase the risk of serious health complications or delays in treatment.

Impacted states: Nationwide

Products:

- TRUE METRIX Blood Glucose Monitoring Systems

- TRUE METRIX AIR Blood Glucose Monitoring Systems

- TRUE METRIX GO Blood Glucose Monitoring Systems

- TRUE METRIX PRO Blood Glucose Monitoring Systems

Contact

For more information, call 1-888-943-2387.

View the original FDA notice

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