HIGH

Trividia Health TRUE METRIX PRO Owner's Booklet Recall for 1,001,534 Units (2026)

Trividia Health recalled 1,001,534 TRUE METRIX PRO owner’s booklets used with glucose meters distributed worldwide through multiple retailers. The labeling fails to clearly warn that an E-5 error could indicate very high blood glucose and does not emphasize immediate actions. Consumers should stop using the device and follow manufacturer recall instructions by letter, contacting Trividia Health or

Quick Facts at a Glance

Recall Date
February 6, 2026
Hazard Level
HIGH
Brand
Trividia Health
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Trividia Health, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

TRUE METRIX PRO is a blood glucose measurement device used by patients to monitor glucose levels. The recall concerns the owner’s booklet and instructions for use supplied with these devices.

Why This Is Dangerous

The labeling does not clearly communicate that the E-5 error could reflect a dangerously high glucose level or the immediate actions required. This ambiguity could delay medical care for patients experiencing high glucose symptoms.

Industry Context

This recall is not described as part of a broader industry safety pattern.

Real-World Impact

Consumers may face delays in treatment if they misinterpret E-5 errors and fail to seek medical attention promptly.

Practical Guidance

How to identify if yours is affected

  1. Review the TRUE METRIX PRO Owner's Booklet and IFU for E-5 error guidance.
  2. Check model numbers RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, RE4068P-01, RE4TVHP03 Rev 56, RE4SUNP03 Rev 56.
  3. If you own the device, stop using it until you receive updated guidance from the manufacturer.

Where to find product info

Owner’s Booklet/IFU for TRUE METRIX PRO devices; model numbers listed above.

What timeline to expect

Timeline for refunds or replacements not specified in available material.

If the manufacturer is unresponsive

  • Document all attempts to contact the manufacturer.
  • Consider consulting a healthcare provider for interim guidance.
  • File a complaint with the manufacturer or relevant regulatory body if needed.

How to prevent similar issues

  • Check labeling when receiving medical device documentation.
  • Ensure urgent actions are clearly stated for error codes.
  • Keep healthcare provider contact information readily available.
  • Follow manufacturer recall communications promptly to minimize risk.

Documentation advice

Save recall notices, communications, and any correspondence with the manufacturer. Photograph the device labeling and store proof of purchase if available.

Product Details

Model numbers: RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, RE4068P-01, RE4TVHP03 Rev 56, RE4SUNP03 Rev 56. Where sold: Worldwide distribution including US, Puerto Rico, Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. When sold: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,001,534 units recalled
  • Worldwide distribution including US, Puerto Rico, Mexico, UK, Jamaica, Trinidad & Tobago, Australia
  • E-5 error code labeling may delay treatment for high blood glucose
  • Stop using the product and follow manufacturer recall instructions
  • Manufacturer: Trividia Health, Inc.
  • Product: TRUE METRIX PRO Owner's Booklet/IFU

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOwner's Booklet / Instructions for Use for TRUE METRIX PRO Blood Glucose Meter
Sold At
Multiple Retailers

Product Details

Model Numbers
RE4H01P-40
RE4H01P-43
RE4212P-00
RE4099P-40
RE4099P-43
+4 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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