The FDA has provided recommendations for patients, caregivers, and health care providers in the “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” FDA Safety Communication. The FDA has identified this recall as a Class I, the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
The FDA is aware that North American Rescue has issued a letter to affected customers recommending first aid kits be corrected prior to continued use.
Affected devices:
| Product Description | Product Code | Lot Number |
|---|---|---|
| KIT, AIDBAG – SMALL – CRISIS 24 | 85-4661 | 85-4661122024 |
| KIT, AIDBAG 1 – V1.0 – SEATTLE PD | 85-4742 | 85-4742123024 |
What to Do
The FDA recommends that consumers and health care providers follow the recommendations provided in the “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” FDA Safety Communication, issued April 28.
North American Rescue sent an Urgent Medical Device Correction letter on March 27 to notify affected customers of the issue.
Reason for Recall
North American Rescue initiated an Urgent Medical Device Correction for first aid kits that contain blood glucose monitors affected by Trividia’s TRUE METRIX Blood Glucose Monitoring System recall.
The Trividia recall is for an issue with the E-5 error code and the instructions for the user in the “Messages” section of the Owner’s Booklets/System Instructions for Use and the online labeling and help guides. The TRUE METRIX meters display the same E-5 Error Code for two different types of issues: 1) a very high blood glucose event (> 600 mg/dL), and/or 2) when there is a test strip error. If a user receives an E-5 Error Code when they are having a very high glucose event, they may not seek appropriate treatment if they think it is a test strip error, or they may delay appropriate treatment as they try to determine what the error means. Alternately, if a user assumes the E-5 Error Code is due to a very high blood glucose event, but they actually have low or normal blood glucose, they may improperly treat themselves for high blood glucose when they actually have low or normal blood glucose. Either a delay in treatment or improper treatment may result in serious adverse health consequences, such as dehydration, altered mental status, loss of consciousness, or death, especially for users with very high or very low blood glucose levels. Trividia has reported 114 serious injuries and one death associated with this recall.
As of March 27, North American Rescue has not reported any serious injuries or deaths associated with this issue.
Device Use
The North American Rescue first aid kits are intended to be used by emergency medics to help during various health emergencies.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Trividia Health at trividia0126CC@trividiahealth.com or call (888) 835-2723.
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
- Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication [04/28/2026]
- Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems [02/17/2026]
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
