Summary: AmeriHealth Caritas Ohio is issuing this provider notice to inform prescribers that, effective May 5, 2026, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall for TRUE METRIX Blood Glucose Monitoring Systems.
Reason for recall
This recall is for an issue with 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:
- A very high blood glucose event (> 600 mg/dL), and/or
- 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. Alternately, if a user assumes the E-5 Error Code is due to a very high blood glucose event, but they have low or normal blood glucose, they may improperly treat themselves for high blood glucose when they 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.
Additional information
The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers that all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring Blood Glucose Systems and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems, including cobranded products sold under store or distribution partner names, have updated use instructions. Affected devices include:
- TRUE METRIX Self-Monitoring Blood Glucose System
- TRUE METRIX AIR Self-Monitoring Blood Glucose System
- TRUE METRIX GO Self-Monitoring Blood Glucose System
- TRUE METRIX PRO Professional Monitoring Blood Glucose System
Trividia is updating the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.
What this means for prescribers
Prescribers should review affected patients and either prescribe an alternative blood glucose meter and compatible test strips or counsel patients who will continue using a TRUE METRIX device to follow the updated E-5 error instructions. If a patient reports an E-5 error code and symptoms of high glucose, instruct the patient to seek immediate medical attention.
Patient support information: Eligible patients may request a free replacement TRUENESS® Blood Glucose Monitoring System, including a meter and test strips, through Trividia Health Customer Support.
Patients may call Trividia Health Customer Support at 1-888-943-2387, Monday-Friday, 8 a.m.-8 p.m. EST (excluding holidays), to sign up to be contacted about a replacement meter.
For official recall and safety information, consumers and health care providers should follow the recommendations in the FDA Safety Communication, “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health”.
Questions
For questions about the updated Owner’s Booklets/System Instructions for Use, contact Trividia Health Customer Care at 1-888-835-2723, Monday-Friday, 8 AM-8 PM EST (excluding holidays) or email trividia0126CC@trividiahealth.com or visit the Trividia Health E-5 product notice page for additional information.
If your patients have questions about pharmacy benefits or need help obtaining coverage for a replacement meter, they may contact Pharmacy Member Services at 1-833-491-0344 (TTY 1-833-655-2437).
Thank you for your cooperation and for the valuable services you provide to our members.
