FDA Medical Device Recall Alert – TRUE METRIX Blood Glucose Monitoring Systems
| Date: | May 13, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Medical Device Recall Alert – TRUE METRIX Blood Glucose Monitoring Systems |
| Business: | Medi-Cal Managed Care/Medicare Dual Special Needs Program (D-SNP) |
On April 28, 2026, the Food and Drug Administration (FDA) released a recall announcement on TRUE METRIX Blood Glucose Monitoring System by Trividia Health.
This is for informational purposes only. You may or may not have prescribed the medical device. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/medical-devices/safety-communicati ons/risks-using-true-metrix-blood-glucose-monitoring-systems-trividia-health-fda-safety-communication?utm_medium=email&utm_source=govdelivery
Recall Issue:
E-5 Error Code display. Due to the handbook instructions, if the error code displays an E-5, this may suggest two things:
- Very high blood glucose of >600mg/dL or
- When there is a test strip error
The member will not be able to identify if it’s a very high blood glucose or a test strip error. The member should not assume one or the other and must seek the appropriate treatment in the case that the blood glucose is high.
Devices Affected:
- TRUE METRIX Self-Monitoring Blood Glucose System
- TRUE METRIX AIR Self-Monitoring Blood Glucose System
- TRUE METRIX GO Self-Monitoring Blood Glucose System
- TRUE METRIX PRO Professional Monitoring Blood Glucose System
Full List of Affected Products: https://www.fda.gov/medical-devices/safety-communications/risks-using-true-metrix-blood-glucose-monitoring-systems-trividia-health-fda-safety-communication?utm_medium=email&utm_source=govdelivery
Recommendations:
Providers to notify members who are currently using the affected TRUE METRIX devices to transition to an alternate blood glucose monitor. Members should continue to test their blood glucose as usual and not stop using their TRUE METRIX meter until they have an alternate blood glucose meter available.
Contact Information:
Health Care Professionals and patients in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Trividia Health at trividia0126CC@trividiahealth.com or 1-888-835-2723.
Distributors, pharmacists, DME providers, and mail order/eCommerce providers in the U.S. with quality problems or questions about this issue should contact Trividia Health at trividia0126CS@trividiahealth.com or 1-800-588-1685
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
