Trividia Health Class I Recall Z-1547-2026

FDA: Device Recalls Class I

Filed March 18th, 2026

Detected March 27th, 2026

Summary

The FDA has issued a Class I recall for Trividia Health's TRUE METRIX AIR blood glucose measuring device kits due to labeling that did not adequately instruct users on how to address the E-5 error code. This recall affects worldwide distribution, including the US, UK, Mexico, Jamaica, Trinidad & Tobago, and Australia.

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What changed

The FDA has initiated a Class I recall (Z-1547-2026) for Trividia Health's TRUE METRIX AIR blood glucose measuring device kits and related instructions for use. The recall stems from inadequate labeling that failed to provide clear directions for lay users to interpret and act upon the E-5 error code, which could indicate a serious issue with the device's functionality.

This recall impacts worldwide distribution, including the United States, Puerto Rico, Mexico, the United Kingdom, Jamaica, Trinidad & Tobago, and Australia. Companies involved in the distribution or sale of these devices should review their inventory and customer communications to ensure compliance with recall procedures and to inform affected users of the potential risks and necessary actions.

What to do next

Review inventory of affected Trividia Health TRUE METRIX AIR kits.
Ensure affected users are informed about the E-5 error code and its implications.
Comply with FDA recall procedures for distribution and return.

Source document (simplified)

Trividia Health, Inc.

Device Recalls (Class I)

← All Device Recalls (Class I) Class I Z-1547-2026 · 20260318 · Ongoing

Product

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit...

Reason for Recall

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 ve...