I use a TRUE METRIX meter. What should I do after the FDA recall?

The FDA says people using affected TRUE METRIX blood glucose meters should switch to another testing method if possible, but should not stop testing until a backup is in place. The problem is that one E-5 error code can mean either a test-strip problem or a glucose reading above 600 mg/dL.

If you use a TRUE METRIX blood glucose meter, the FDA says the safest next step is to make a plan to switch to another way to check your blood sugar if possible. But the agency also says people should not stop testing until they actually have a backup method available.

The warning centers on the meter’s E-5 message. On affected devices, E-5 can mean two very different things: either a test-strip error or a very high blood sugar reading above 600 mg/dL. If someone guesses wrong, they could delay urgent treatment or treat themselves for the wrong problem.

What happened

The FDA issued a safety communication on April 28, 2026, about TRUE METRIX blood glucose monitoring systems made by Trividia Health. The agency updated that communication on May 19, 2026, after Trividia sent an updated correction notice on May 1, but the FDA said its recommendations for patients and caregivers did not change.

The FDA has identified this as a Class I recall, the agency’s most serious recall category. According to the FDA, the problem is tied to the software design and labeling for the E-5 error code. As of January 16, 2026, Trividia had reported 114 serious injuries and one death associated with this issue.

Which meters are affected

The recall covers all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO self-monitoring blood glucose systems, along with TRUE METRIX PRO professional monitoring systems. The FDA also says affected products include co-branded versions sold under store or distribution partner names, so some people may have an impacted meter that does not say TRUE METRIX on the front.

If you are not sure whether your meter is included, check the FDA’s affected-product list or compare the product name on your meter and supplies with any notice you received from your pharmacy, supplier, clinic, or health plan.

Why the E-5 error is dangerous

Usually, an error message points to one clear issue. Here, the same E-5 code can mean either a very high glucose event above 600 mg/dL or a test-strip error.

That is the core safety problem. Someone who assumes E-5 only means a strip issue could miss a dangerously high reading. Someone who assumes E-5 always means severe hyperglycemia could treat for high blood sugar when their level is actually normal or low. The FDA warns that delayed or improper treatment can lead to dehydration, altered mental status, loss of consciousness, or death.

What FDA wants users to do now

  • Seek another way to test blood glucose, if possible, until corrected meters become available.
  • Do not stop testing with your current TRUE METRIX meter until you have another method ready.
  • Talk with your clinician or pharmacist about which alternative system makes sense for you.
  • If you use a continuous glucose monitor, remember that CDC patient guidance says CGM users still need blood glucose meter checks to help confirm CGM accuracy.

The American Diabetes Association says blood glucose monitoring is a primary tool for knowing whether glucose is in range. The group notes that regular checking may be especially important for people taking insulin, people who are pregnant, people who have low blood sugar, people having trouble reaching targets, and people who have ketones from high blood sugar.

Who needs the fastest transition plan

The FDA says it is especially important to transition quickly if you use intensive insulin therapy, take sulfonylureas, or have frequent high- or low-blood-sugar events. In plain language, that includes people whose treatment decisions depend on meter readings several times a day and people whose glucose can swing low or high without much warning.

CDC guidance also notes that people with type 1 diabetes, people with type 2 diabetes who use insulin, and people who often have low blood sugar may need to check more often than others.

What to do if you get an E-5 error today

Do not assume you know what E-5 means. Treat it as an unclear result, not a confirmed strip problem and not a confirmed very high reading.

  • If you have symptoms of low or high blood sugar when E-5 appears, the FDA says to contact your health care provider right away for help deciding what to do next.
  • If you already have a backup meter or another clinician-approved testing method, use that to recheck.
  • If you are sick and a backup test shows blood sugar at 240 mg/dL or higher, CDC says to check for ketones if you can and call your doctor if ketones are high.
  • Do not make sudden changes to insulin, sulfonylureas, or other diabetes medicines on your own because of one unclear meter message.

High ketones can be an early sign of diabetic ketoacidosis, or DKA, which is a medical emergency.

Emergency warning signs

Get emergency help right away if you have signs of a severe blood-sugar emergency, especially confusion, altered mental status, trouble staying conscious, or loss of consciousness.

CDC says DKA warning signs can include being very thirsty, urinating much more than usual, dry mouth, fast or deep breathing, fruity-smelling breath, nausea, vomiting, stomach pain, headache, and extreme tiredness. Go to the emergency room or call 911 right away if your blood sugar stays at 300 mg/dL or above on backup testing, you are vomiting and cannot keep food or drinks down, you are having trouble breathing, or you have multiple signs of DKA.

How to get help

  • Ask your clinician or pharmacist which blood glucose meter or other testing option you can use as a backup.
  • Check whether your current meter is on the FDA’s affected-product list, especially if it was sold under a store or partner brand.
  • Report device problems or complications to FDA MedWatch and to Trividia Health.

What is still uncertain

As of June 5, 2026, the FDA says users should seek an alternative testing method until corrected meters become available, but the public safety communication does not give a public release date for corrected devices. That means many users may need a temporary transition plan rather than a quick one-time fix.

The bottom line: if you use a TRUE METRIX meter, make a backup plan now, keep testing until that backup is ready, and treat any E-5 message as a potentially serious warning that needs context rather than guesswork.

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.