URGENT MEDICAL DEVICE CORRECTION – UPDATED

Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems

The purpose of this notice is to provide an important update on Trividia Health’s (“Trividia” or “we”), medical device labeling correction that was 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 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.

Instructions for Locating the Serial Number on the back of the Meter

On the back of the TRUE METRIX® Self-Monitoring Blood Glucose Meter, check the Serial Number (SN), including the letters and digits.

To check if you have any affected meters:

Please enter the TRUE METRIX meter Serial Number below to see if you have an affected meter:

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 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 when the upgrade program becomes available.

Reminder of Labeling Correction: E-5 Error Code Message:

The initial communication on February 6, 2026, included information for the labeling correction that impacts the Owner’s Booklets included with the meter at purchase.. The test strips and control solution are not impacted. Please refer to the information noted above for People with Diabetes.

The correction involves the E-5 Error Code in the “Messages” section of the Owner’s Booklets. The system displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

Trividia is updating the E-5 Error Code actions to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.

Users will already be seeing the new E-5 Error Code message in meter boxes and in TRUE METRIX test strip boxes.

UPDATED E-5 INSTRUCTIONS for TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO:

UPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO:

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 (listed below).

Co-Branded Product Names
Care One (Ahold)
CenterWell (Humana)
CVS
Discount Drug Mart
Foster & Thrive/Sunmark/Healthmart (McKesson)
Good Neighbor Pharmacy (Cencora)
HEB
Henry Schein
HyVee
Kroger
Leader (Cardinal Health)
McKesson (Med Surg)
Meijer
ProCure (WynnMed)
Publix
Relion (Walmart)
Rite Aid
Signature Care (Albertsons)
Top Care (TopCo)
Walgreens

WHAT YOU SHOULD DO:

Distributors: Please notify your customers immediately of this correction update. Include this letter in your notification and ask that they notify their customers or facilities if they have further distributed the Products. Complete and return the Acknowledgement form on page 4 by email to Trividia4036@sedgwick.com or fax at: 1-888-965-6125, to confirm that you have received this updated notice and have notified your customers. 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). Products are not to be returned, and in accordance with the information noted above we will notify users of the product upgrade in the near future.

Pharmacists/DME Providers: Please notify your stores/providers immediately of this correction update. Include this letter in your notification and ask that they notify their customers or facilities if they have further distributed the Products. Complete and return the Acknowledgement form on page 4 by email to Trividia4036@sedgwick.com or fax at: 1-888-965-6125, to confirm that you have received this updated notice and have notified and/or posted the notice for your stores/locations. 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). Products are not to be returned and in accordance with the information noted above we will notify users of the product upgrade in the near future.
o RETAIL PHARMACIES: Consider communicating this correction to your patients using a TRUE METRIX meter and post the updated “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 5 in areas where the Products are sold.

Mail Order/eCommerce Providers: Please notify your customers who use these Products immediately of this correction update. You may use the updated “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 5. Complete and return the Acknowledgement form on page 4 by email to Trividia4036@sedgwick.com or fax at: 1-888-965-6125, to confirm that you have received this updated notice and have notified your customers. 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). Products are not to be returned, and in accordance with the information noted above we will notify users of the product upgrade in the near future.

Health Care Professionals: Please notify your providers and patients who use these Products immediately of this correction update. You may use the updated “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 5. Complete and return the Acknowledgement form on page 4 by email to Trividia4036@sedgwick.com or fax at: 1-888-965-6125, to confirm you have received this updated notice and have notified your patients. 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). Products are not to be returned, and in accordance with the information noted above we will notify users of the product upgrade in the near future.

    • FOR FACILITIES WITH MULTIPLE PATIENTS: Please post the updated “URGENT MEDICAL DEVICE CORRECTION”HCP notice provided on page 6 in areas where the Products are stored within your facility to notify personnel of this labeling correction.

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 meter 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.

  • Contact Trividia Health’s Customer Support Department to be provided with a TRUENESS® Blood Glucose Monitoring System (Meter and Test Strips), at no-charge, by calling 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. Products are not to be returned, and in accordance with the information noted above we will notify users of the product upgrade in the near future.

Trividia Health has notified the U.S. Food and Drug Administration (FDA) of this action.

If you would like to view additional information, please click here for the:

PRESS RELEASE
CUSTOMER COMMUNICATION
LIST OF IMPACTED PRODUCTS

Click here to view updated TRUE METRIX, TRUE METRIX AIR and TRUE METRIX GO Owner’s Booklets

Click here to view updated TRUE METRIX PRO Owner’s Booklet

Patient safety is our top priority, and we apologize for any inconvenience this correction may cause you.