What to do if you use a TRUE METRIX meter after the FDA Class I recall

ByBrian “Weence” Bateman

FDA says people using recalled TRUE METRIX meters should switch to another way to test blood sugar if possible, but should keep testing until an alternative is available.

If you use a TRUE METRIX blood glucose meter, the FDA says this recall needs prompt attention. The core problem is not that every reading is wrong. It is that one error code, E-5, can mean two very different things: a very high blood sugar level above 600 mg/dL or a test-strip error.

The practical takeaway is not to stop checking your blood sugar. FDA says users should move to another testing method when possible, but should keep testing with their current TRUE METRIX meter until another option is available. People at highest risk include those on intensive insulin therapy, people taking sulfonylureas, and people who often have very high or very low blood sugar.

What happened

FDA issued a safety communication on April 28, 2026, about risks linked to TRUE METRIX blood glucose monitoring systems made by Trividia Health. The agency updated that page on May 19, 2026, to add information about an updated company notice sent on May 1. FDA said its recommendations for patients and caregivers did not change.

The issue was first communicated publicly in February 2026. FDA later identified it as a Class I recall, the agency’s most serious recall category. In FDA language, that means there is a reasonable chance the device issue could cause serious injury or death if the recommendations are not followed.

Which meters are affected

The recall applies to these TRUE METRIX families:

  • TRUE METRIX
  • TRUE METRIX AIR
  • TRUE METRIX GO
  • TRUE METRIX PRO

It also includes co-branded versions sold under store or distribution partner names. So this is not limited to one label on the front of the meter. Some pharmacy and store-branded versions are included too.

Why the E-5 message is risky

According to FDA, the same E-5 code may appear for two different situations: a very high blood glucose event above 600 mg/dL or a test-strip error. That creates a dangerous problem. A person may think the code is only a strip problem and delay care for severe hyperglycemia. Or they may assume it means extremely high blood sugar and respond as if they are high when their glucose may actually be normal or even low.

That confusion matters because treatment delays and wrong treatment can both be harmful. FDA says delayed recognition of very low or very high blood sugar can lead to serious complications, including dehydration, altered mental status, loss of consciousness, or death. As of January 16, 2026, Trividia had reported 114 serious injuries and one death associated with this issue to FDA.

For context, CDC says typical blood sugar targets are 80 to 130 mg/dL before a meal and less than 180 mg/dL two hours after the start of a meal, although each person may have a different target range. A glucose event above 600 mg/dL is far outside those usual targets and may be dangerous.

Who should try to switch first

FDA says all TRUE METRIX users should seek an alternative method for testing blood glucose, if possible, until corrected meters become available. But the agency says some people should move fastest:

  • People using intensive insulin therapy
  • People taking sulfonylureas
  • People who have frequent hyperglycemia or hypoglycemia episodes

These groups may be more vulnerable to harm if a wrong reading or a misunderstood error code leads to delayed or incorrect action.

Symptoms that make this urgent

If you get an E-5 code and also feel symptoms of low or high blood sugar, FDA says to contact your health care provider right away for help deciding what to do.

NIDDK says low blood sugar can come on quickly. Warning signs can include feeling shaky or jittery, hungry, tired, dizzy, lightheaded, confused, irritable, or like your heart is beating too fast or unevenly. Headache and trouble seeing or speaking clearly can also happen. Severe hypoglycemia can lead to loss of consciousness or seizure and needs immediate treatment.

High blood sugar can cause symptoms such as frequent urination, increased thirst, and rising glucose levels. The American Diabetes Association warns that untreated hyperglycemia can progress to ketoacidosis, which is life-threatening and needs immediate treatment. Symptoms can include shortness of breath, breath that smells fruity, nausea, vomiting, and very dry mouth.

CDC says that if you are sick and your blood sugar is 240 mg/dL or above, you should check for ketones. High ketones can be an early sign of diabetic ketoacidosis, which CDC describes as a medical emergency.

Get emergency care right away for seizure, loss of consciousness, severe confusion, trouble breathing, or symptoms that suggest ketoacidosis, such as fruity-smelling breath with vomiting or very dry mouth.

What to do now if you use one of these meters

  • Do not stop checking your blood sugar. FDA says to keep testing until you have another method available.
  • Talk with a pharmacist or clinician about an alternative system. Ask what other meter or monitoring option may work for you.
  • Treat an E-5 code seriously. Do not assume it means only a strip problem.
  • If you have symptoms of low or high blood sugar with an E-5 code, contact your health care provider immediately.
  • If severe symptoms are present, get emergency care. Trouble breathing, loss of consciousness, seizure, or signs of ketoacidosis should not wait.
  • Report problems. FDA asks patients and caregivers to report complications or device problems to MedWatch and to Trividia Health.

What is known and what is still unclear

What is known is that FDA kept its patient recommendations in place after the May 19, 2026 update. The affected products include all major TRUE METRIX meter families, including store-branded versions, and the agency wants users to move to another testing method when possible.

What is still unclear for any one person in real time is whether a specific E-5 event reflects a strip problem or a dangerously high glucose event. That uncertainty is exactly why the recall matters. FDA says it is continuing to monitor device performance reports and will update the public if significant new information becomes available.

If you rely on one of these meters, the most useful next step is a practical one: make a plan now with your pharmacist or diabetes clinician for a different way to test, and know which symptoms mean you should seek urgent or emergency care.

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.

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Brian “Weence” Bateman is a health and medical writer who covers public health updates, healthcare policy, and medical developments affecting communities across the United States. He works closely with dentists and healthcare providers and focuses on making complex medical information clear, accurate, and useful for everyday readers.