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...

Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.