Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems

Date

Feb 6, 2026

Company

Trividia Health, Inc.

Brand

TRUE METRIX

Product

Blood Glucose Monitoring Systems

Reason

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.

Hazard

Other

Source

FDA

How to identify the product

• 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.
• Since August 2014, when TRUE METRIX was launched globally, there have been 114 reported serious injuries, and one (1) death associated with the E-5 Error Code.
• The correction affects all TRUE METRIX branded Blood Glucose Meters distributed in the United States, United Kingdom, Mexico, Australia and the Caribbean.
• This includes our cobranded products sold under store or distribution partner names.
• The company is sending the 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.

Product photos are on the official FDA page.

Official notice (FDA)

Facts are taken from the official notice. If anything here differs from it, the official notice is correct.