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TRUE METRIX Blood Glucose Meter Owner's Booklets
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MEDICAL DEVICE RECALLCRITICAL

TRUE METRIX Blood Glucose Meter Owner's Booklets

Trividia Health is recalling TRUE METRIX meter manuals due to inadequate instructions for handling the E-5 error code.

What to do

Review the updated instructions for use provided by the manufacturer. If you receive an E-5 error code on your meter and are experiencing symptoms of high blood glucose, contact your healthcare professional immediately.

Posted
Updated
Recall No.
Z-1546-2026
Agency
Firm
Trividia Health, Inc.
Recall ID
98317
Status
ONGOING

Why it was recalled

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

How to identify it

UPC 21292006099 21292006105 10840330705681 21292014919 21292008673 20612479197217 607415261097

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item:

Recalled lots

DISPLAY: SEE IMAGE BELOW, REASON: Very high blood glucose / result (higher than 600 mg/dL), / Or Test Strip Error, ACTION: 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.

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification