Short summary: FDA has warned people using TRUE METRIX blood glucose monitoring systems to move to another testing method when possible. The safety issue involves an E-5 error code that can represent either very high glucose or a test strip problem, which may lead to delayed or incorrect treatment decisions.
Safety note: This alert is about TRUE METRIX systems, not all glucose meters. Do not stop monitoring blood glucose abruptly. FDA says users should continue testing until another testing method is available.
Key takeaways
- FDA says the recall affects TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO systems, including some cobranded products.
- FDA recommends switching to another blood glucose testing method when possible.
- Users should keep checking glucose and should not stop using their meter until an alternative is available.
- FDA highlights higher risk for people using intensive insulin therapy, people taking sulfonylureas, and people with frequent high or low glucose episodes.
What FDA reported
FDA issued a safety communication about TRUE METRIX blood glucose monitoring systems made by Trividia Health. The communication was issued on April 28, 2026 and updated on May 19, 2026. FDA said Trividia Health issued an updated urgent Medical Device Correction notice to affected customers.
The affected systems include TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO systems, including cobranded products sold under store or distribution partner names. This alert is specific to TRUE METRIX systems. It is not a warning about every glucose meter brand.
FDA describes the related TRUE METRIX correction as a Class I recall, the agency’s most serious recall category. That classification does not mean every user has been harmed, but it does mean the issue can cause serious health consequences if it leads to unsafe treatment decisions.
What is the E-5 error problem?
According to FDA, TRUE METRIX meters can show the same E-5 error code for two different situations: a very high glucose reading above 600 mg/dL, or a test strip error. Those are very different problems. Treating them the same way can be unsafe.
If someone thinks the code is only a strip error, they may delay care for true severe hyperglycemia. If someone assumes the code means very high glucose when the glucose is actually normal or low, they may treat themselves in the wrong direction. That is why FDA recommends arranging another testing method instead of trying to interpret repeated E-5 errors alone.
Why this matters
Blood glucose readings guide real decisions: insulin doses, food choices, driving safety, exercise, sick-day plans, and when to seek help. FDA reported 114 serious injuries and one death associated with this issue as of January 16, 2026.
The risk is higher for people who rely on frequent and accurate readings, including people using intensive insulin therapy, people taking sulfonylureas, and people who often have high or low glucose readings.
What users should check
If you use a TRUE METRIX meter, check the FDA safety communication and Trividia Health materials for the latest product information. Device lists and manufacturer instructions may change. If you are unsure whether your meter or strips are affected, bring the meter, strip vial, packaging, or photos of labels to your pharmacist, diabetes educator, or diabetes clinic.
FDA recommends transitioning to another testing method when possible. That may mean another finger-stick meter or another glucose monitoring plan arranged through a clinician, pharmacy, insurer, or diabetes supply provider.
Do not stop testing abruptly
The safest message is not “throw the meter away today.” FDA says users should continue testing blood glucose and should not stop using their TRUE METRIX meter until they have another method available.
If you receive an E-5 error and have symptoms of high or low glucose, contact a health care professional for help deciding what to do next. Severe symptoms such as confusion, loss of consciousness, seizure, repeated vomiting, or signs of diabetic ketoacidosis require urgent medical care. Do not rely on repeated home testing alone when symptoms are severe.
How to reduce risk while switching
- Do not make major treatment changes from one unexpected reading without checking your care plan.
- If a reading does not match how you feel, follow your backup testing or care-team instructions.
- Keep fast-acting carbohydrate available if you are at risk for low blood sugar.
- Ask your pharmacist or insurer which alternative meter and strips are covered.
- Report meter problems to FDA and Trividia Health.
For related safety reading, see our guides on fear of hypoglycemia, driving with diabetes, and exercise planning when hypoglycemia risk matters.
Practical takeaway
If you use TRUE METRIX, check the FDA notice and arrange an alternative testing method when possible. Keep monitoring glucose until that alternative is in place. If an E-5 error appears and you feel symptoms of high or low glucose, get help rather than guessing.
Sources
- FDA: TRUE METRIX Blood Glucose Monitoring Systems Safety Communication
- FDA: Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems
Editorial review note: reviewed for medical accuracy, source consistency, patient-safety framing, plain-language readability, and non-alarmist wording before publication.