HIGH

12 Million TRUE METRIX Blood Glucose Meters Recalled Due to E-5 Error Code Risk

Trividia Health recalled 12,067,458 TRUE METRIX blood glucose meters sold worldwide due to inadequate labeling. The manuals failed to emphasize that an E-5 error code could indicate a dangerously high blood glucose level. Users must stop using these devices immediately and contact their healthcare provider for further instructions.

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 blood glucose meters are widely used by individuals monitoring their blood glucose levels, especially those with diabetes. These devices provide vital measurements to help manage health and prevent emergencies related to blood sugar levels.

Why This Is Dangerous

The E-5 error code may indicate critical health issues, but the current labeling fails to instruct users to seek immediate medical attention. This could inadvertently lead users to neglect necessary healthcare responses when facing symptoms of high blood glucose.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Users may face significant safety risks due to the potential for mismanagement of high blood glucose levels, leading to serious health complications.

Practical Guidance

How to identify if yours is affected

  1. Locate your TRUE METRIX device and check the model number against the recalled models.
  2. If your device shows an E-5 error code, take it seriously and contact a healthcare professional immediately.
  3. Check any recent communications from your healthcare provider regarding the recall.

Where to find product info

Model numbers can typically be found on the device itself or within the user manual.

What timeline to expect

You can expect a refund or resolution within 4-6 weeks after submitting your request.

If the manufacturer is unresponsive

  • Follow up via phone or email.
  • Escalate the issue through consumer protection agencies if needed.

How to prevent similar issues

  • Always check for product recalls before purchasing medical devices.
  • Ensure user manuals explicitly detail error codes and any necessary actions.
  • Choose products from reputable manufacturers with a history of safety compliance.

Documentation advice

Keep detailed records of all communications regarding the recall, and photograph the device and any damage or issues as evidence.

Product Details

Models affected include Walgreens TRUE METRIX Kit/RE4001-01, CVS TRUE METRIX Kit/RE4007-01SB, and others. Products were sold nationwide in the U.S. and in countries including Mexico, the United Kingdom, and Australia. The recall was issued on February 6, 2026.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 12,067,458 units recalled
  • Risk of delayed treatment due to inadequate instructions
  • Users must contact healthcare professionals immediately if E-5 code appears
  • Sold worldwide including U.S., Mexico, UK, and Australia
  • Recall issued on February 6, 2026
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeBlood Glucose Meter
Sold At
Multiple Retailers

Product Details

Model Numbers
RE4001-01
RE4002-01
RE4002-40
RE4007-01SB
RE4011-00
+15 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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