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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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 6, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Trividia Health
Product type
Blood Glucose Meter
Model numbers
RE4001-01, RE4002-01, RE4002-40, RE4007-01SB, RE4011-00, RE4011-01, RE4019-01, RE4023-01 +12 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 6, 2026

  2. Reported by FDA DEVICE

    March 18, 2026

  3. RecallRadar source check

    April 21, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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.

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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

  • 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

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 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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