Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems
Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems
FT. LAUDERDALE, Fla.--(BUSINESS WIRE)--Trividia Health, Inc., a global leader in diabetes management, today provided an important update to the medical device labeling correction it announced on February 6, 2026, for all TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO Blood Glucose Monitoring Systems (collectively, the “Products”).
Since the February 6, 2026 communication, Trividia Health has been actively updating the labeling and providing messaging to ensure that users are aware of the updated instructions for the E-5 Error Code. Users will already be seeing the new E-5 Error Code message in TRUE METRIX Meter boxes and in test strip boxes.
In coordination with the U.S. Food and Drug Administration (FDA), we continue to develop our long-term corrective strategy and wish to communicate certain key updates to users.
Message to People currently managing their Diabetes with TRUE METRIX, TRUE METRIX AIR or TRUE METRIX GO branded Blood Glucose Meters:
Delayed recognition of extremely low or extremely high blood glucose levels could increase the risk of serious health complications or delays in treatment. Your safety is our top priority.
For People with Diabetes, if possible, consider transitioning to an alternative method of testing your blood glucose (blood sugar), otherwise you should continue using your TRUE METRIX meter. Patients continuing to use their TRUE METRIX device should follow the updated instructions if they receive an E-5 Error Code. People with Diabetes who rely on intensive insulin therapy, sulfonylureas, or glucose monitoring due to frequent hypo- or hyperglycemia events are at highest risk and should consider transitioning to an alternative testing method until the updated TRUE METRIX blood glucose test system becomes available.
If you have questions or concerns as to whether TRUE METRIX is appropriate for you, based on an understanding of your individual risk factors, please discuss with your healthcare provider or pharmacist.
Updated TRUE METRIX Meters and Future Upgrade Program
As part of its commitment to continuous improvement and patient safety, Trividia Health has determined that developing updated software for TRUE METRIX meters will provide the most effective long-term solution. In coordination with the FDA, we are diligently working on these updates.
We anticipate that updated meters will become available across the TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO branded Blood Glucose Meters in the near future, after which Trividia Health will initiate a comprehensive upgrade program to replace meters currently in the field.
Trividia Health will notify users of the future Upgrade Program when it is available.
If you have any questions, please call our Customer Support Department toll-free at 1-888-943-2387 Monday-Friday 8AM-8PM EST (excluding holidays) or visit https://truemetrixmeters.expertinquiry.com to sign up to be contacted, or visit www.trividiahealth.com/E-5productnotice for more information.
This 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. This includes our cobranded products sold under store or distribution partner names. Please refer to the updated Product Notice located at www.trividiahealth.com/E-5productnotice for more information on the list of co-brand partners, customer notices and updated TRUE METRIX owner’s booklets. Additional information that can be found online includes a Serial Number search tool for impacted products.
The company is sending an updated Product Notice to impacted customers with instructions on what to do, to post the notice where products are stored/sold, and to forward the notice to device users, if possible. These customers include pharmacies, mail order companies, and distributors where the TRUE METRIX® meters are sold. Please refer to the updated Product Notice located at www.trividiahealth.com/E-5productnotice for more information.
Trividia Health has notified the U.S. Food and Drug Administration (FDA) of this action.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form or submit by fax to 1-800-FDA-0178.
Patient safety is our top priority, and we apologize for any inconvenience this correction may cause you.
About Trividia Health
Trividia Health, Inc., is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service providers. For more information, please visit: www.TrividiaHealth.com .
Contacts
Media Contact: Annmarie Ramos
(800) 342-7226, ext. 3190
