Fort Lauderdale, FL, United States
Trividia Health, Inc. recalls
3 recalls recorded since 2018, most recently on 6 February 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 6 February 2026
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1546-2026, Z-1547-2026, Z-1548-2026, Z-1545-2026
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE T
- 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/REA4002-01, CVS TRUE
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE ME
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX
Ongoing Class II Medical devices
- Recall started
- 7 October 2025
- Reason
- Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
- Distribution
- US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0413-2026
- Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Terminated Class II Medical devices
- Recall started
- 20 April 2020
- Terminated
- 1 June 2021
- Reason
- One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.
- Distribution
- US Nationwide distribution including in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2201-2020
- TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.