Trividia Health Class I Device Recall

FDA: Device Recalls Class I

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA has announced a Class I device recall for Trividia Health's TRUE METRIX PRO blood glucose meters and associated owner's booklets/instructions for use. The recall is due to labeling that may not adequately direct users on how to respond to an E-5 error code, potentially delaying treatment for high blood glucose levels.

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What changed

The U.S. Food and Drug Administration (FDA) has classified a recall initiated by Trividia Health, Inc. as a Class I recall, the most serious type, concerning their TRUE METRIX PRO blood glucose meters and related owner's booklets and instructions for use. The recall, identified by recall number Z-1546-2026, stems from inadequate labeling that fails to clearly emphasize the potential severity of an E-5 error code and the immediate need to contact a healthcare professional. This deficiency could lead to delayed treatment for users experiencing high blood glucose levels.

This action impacts approximately 1,001,534 devices distributed worldwide. Healthcare providers and patients using these devices should be aware of the potential for misinterpretation of the E-5 error code. While the recall is voluntary and firm-initiated, the FDA's classification highlights the critical nature of the issue. Regulated entities involved in the manufacturing or distribution of similar devices should review their labeling to ensure clarity and completeness, particularly regarding error codes and recommended user actions, to prevent potential patient harm and ensure compliance with FDA regulations.

What to do next

Review Trividia Health TRUE METRIX PRO meter labeling for E-5 error code instructions.
Ensure all user manuals and labeling for blood glucose monitoring devices clearly emphasize critical error codes and immediate actions.
Consult with healthcare professionals regarding any user concerns about E-5 error codes.

Source document (simplified)

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