FDA warns about TRUE METRIX blood glucose meter recall

The FDA says people using TRUE METRIX blood glucose systems should keep testing for now, but should transition to another meter when possible. The concern is an E-5 error code that can be confused with either a very high glucose reading or a test strip problem, which could delay the right response.

The FDA issued a safety communication on April 28, 2026, warning consumers and health care providers about risks tied to Trividia Health’s TRUE METRIX blood glucose monitoring systems. The agency says users should keep testing their blood sugar for now, but should move to an alternative glucose monitoring method when possible.

The recall matters because the meter’s E-5 error code can point to two different problems: a very high blood glucose reading or a test strip error. That kind of confusion can delay treatment or lead someone to respond to the wrong problem.

What the FDA announced

According to the FDA, the recall affects TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO systems, including some co-branded store and distributor products. The FDA identified the action as a Class I recall, its most serious recall category.

As of January 16, 2026, Trividia Health had reported 114 serious injuries and one death associated with the issue. That figure reflects reported events reviewed by the company and FDA; it does not mean every case was caused in the same way.

Why the E-5 error code is a problem

The issue is not just that the meter shows an error. It is that the same E-5 code can appear for two different situations: a glucose reading above 600 mg/dL or a test strip error. If a person thinks the code means the strips are faulty, they may delay care during a dangerous high-glucose event. If they assume it means a very high reading when their glucose is actually normal or low, they may treat the wrong problem.

Either mistake can be harmful, especially for people who are already at higher risk from glucose swings.

Who should move fastest

The FDA says it is especially important for people at highest risk to transition to another monitoring system as soon as possible. That includes people on intensive insulin therapy, people taking sulfonylureas, and people who have frequent high or low glucose events.

Caregivers, family members, and facility staff should also know which patients use affected meters so they can help with the switch and understand what to do if an E-5 error appears.

What readers should do now

The FDA says not to stop testing. Keep using the TRUE METRIX meter until another way to check blood glucose is available. At the same time, contact a health care provider or pharmacist about switching to a different glucose monitoring system.

If an E-5 code appears and the person has symptoms of low or high blood sugar, the FDA says they should contact a clinician right away for help deciding what to do next.

When low or high blood sugar becomes urgent

Low blood sugar can cause shakiness, sweating, confusion, dizziness, and a fast heartbeat. The CDC says severe low blood sugar can lead to trouble walking or seeing clearly, seizures, fainting, and a need for help from another person.

The CDC recommends the 15-15 rule for many mild lows: take 15 grams of fast-acting carbohydrates, wait 15 minutes, and recheck. For severe low blood sugar, injectable glucagon is the best treatment, and emergency medical help should follow.

Very high blood glucose can also be dangerous. Symptoms may include extreme thirst, frequent urination, dehydration, confusion, or loss of consciousness. Anyone who is severely ill, cannot stay awake, cannot swallow, has seizures, or seems confused needs urgent medical attention.

What clinicians and caregivers can tell patients

The FDA recommends that health care providers notify affected patients and help them identify an alternative testing method. In practical terms, that means confirming which meter a patient uses, reviewing backup testing options, and making sure the patient and caregiver know how to respond to low or high readings.

MedlinePlus notes that blood glucose meters are the most common home-testing tool, while continuous glucose monitoring may be especially useful for people who take insulin and have problems with low blood glucose. That can help frame a conversation about replacement options.

Where to report problems

The FDA says people should report problems or complications with the meter to the agency and to Trividia Health. The FDA’s recalls, market withdrawals, and safety alerts page is the best place to check for related updates and the full recall notice.

Sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.