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
- 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.
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 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
- Locate your TRUE METRIX device and check the model number against the recalled models.
- If your device shows an E-5 error code, take it seriously and contact a healthcare professional immediately.
- 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
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Safety Guide
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