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 Monitoring System
- Model numbers
- RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567 +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 GO is a blood glucose monitoring system used to measure blood sugar levels. It is distributed through multiple retailers worldwide and includes owner’s booklets and instructions.
Why This Is Dangerous
Labeling failed to clearly emphasize that E-5 could indicate dangerously high blood glucose and did not prominently instruct immediate action. This may delay treatment during high glucose events.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may experience delays in recognizing dangerous hyperglycemia. The recall emphasizes consuming urgent action rather than relying on ambiguous labeling.
Practical Guidance
How to identify if yours is affected
- 1. Check the device label, owner’s booklet or IFU for E-5 error code.
- 3. Stop using if your kit matches any listed model numbers.
- 4. Contact Trividia Health or your healthcare provider for instructions.
Where to find product info
Look for the model numbers in the device, its owner’s booklet or Instructions for Use. International variants have separate RF codes.
What timeline to expect
Recall actions typically complete within 4-8 weeks for replacements or updated labeling.
If the manufacturer is unresponsive
- File a complaint with the CPSC if the company remains unresponsive
- Keep documentation of all communications and responses
- Consider seeking legal guidance if the issue persists and affects health outcomes.
How to prevent similar issues
- Verify labeling when purchasing glucose monitoring systems.
- Ensure owner’s manuals clearly address emergency codes like E-5.
- Ask retailers for updated labeling or replacement kits.
- Follow manufacturer guidance for any recalls.
Documentation advice
Keep the recall notification, model numbers, photos of labels and manuals, and all email/phone correspondences with the manufacturer.
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Product Details
Model numbers and related items include RF4001-01BK, RF4007-01, RF4019-01, RF4023-01, RF4031-01, RF4048-01, RF4066-01, RF4209-01, RF4H01-01BK, RF4H01-40, RF4i29-11BK, RF4i81-11BK, RF4i82-11BK, RF4i82-12BK, RF4TVH03 Rev 57 and prior, RF4TVH35 Rev 51 and prior, RF4ITV16 Rev 55 and prior, RF4UKT16 Rev 56 and prior, RF4LAT16 Rev 51 and prior, RF4AUT16 Rev 57 and prior. Description covers Owner’s Booklets and Instructions for Use used with TRUE METRIX GO kits sold worldwide. Distribution: 1,407,465 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1.4 million units distributed worldwide
- TRUE METRIX GO labeled kits and owner’s booklets affected
- E-5 error misinterpretation is the core labeling issue
- Manufacturer: Trividia Health
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Safety Guide
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