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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Owner's Booklet / Instructions for Use for TRUE METRIX PRO Blood Glucose Meter
- Model numbers
- RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, RE4068P-01, RE4TVHP03 Rev 56 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 6, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 21, 2026
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 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
- Review the TRUE METRIX PRO Owner's Booklet and IFU for E-5 error guidance.
- Check model numbers RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, RE4068P-01, RE4TVHP03 Rev 56, RE4SUNP03 Rev 56.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- 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
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.