Recall archive / FDA company announcement

TRUE METRIX: Blood Glucose Monitoring Systems — FDA announcement Feb 6, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Feb 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Not supplied
Recalling firm: Trividia Health, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 4c017eac42898fea

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Display \| Reason \| Action; SEE IMAGE BELOW \| Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error \| WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

Label field

Details supplied by the agency

Lot, code or applicability

Display | Reason | Action; SEE IMAGE BELOW | Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error | WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Display	Reason	Action
SEE IMAGE BELOW	Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error	WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

FDA company announcement, table 2
Display	Reason	Action
SEE IMAGE BELOW	Very high blood glucose result (higher than 600 mg/dL), Or Test Strip Error	WARNING!! Retest with a new test strip. If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately. If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

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. Please refer to the Product Notice located at www.trividiahealth.com/E-5productnotice for more information. You may continue to use the TRUE METRIX® Products. Products are not to be returned or replaced. This correction does not require removal of the Products from where they are used or sold. This labeling correction impacts the Owner’s Booklets/System Instructions for Use that accompany the meters at purchase, as well as the online labeling and help guides located on Trividia Health’s website. Trividia Health will notify users of additional mitigation strategies as needed.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Feb 6, 2026
Company announcement date: Feb 6, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.