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FDA Classifies TRUE METRIX Glucose Monitor Correction as Class I Recall

Vetted by Stefan Rest 2 min read

The FDA has classified a correction for TRUE METRIX blood glucose meters as a Class I recall, its most serious type. The problem is one error message, E-5, that can mean two very different things. The FDA says that confusion may lead people to delay care or treat themselves the wrong way. Here is what the recall covers and what the FDA has reported.

Which meters are involved

The recall covers four systems made by Trividia Health:

  • 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

The FDA says it also covers versions sold under store or distributor names. Many of these carry a pharmacy name on the box.

The E-5 problem

These meters test a drop of blood on a strip. When something goes wrong, the meter can show E-5. But E-5 can mean either of two things: blood sugar above 600 mg/dL, or an error with the test strip.

The FDA says that creates two risks. A person with very high blood sugar may think the strip failed and put off care. Or a person may treat E-5 as very high blood sugar when their level is actually normal or low. The FDA says either mistake could lead to dehydration, confusion, loss of consciousness or death.

The FDA traces the issue to the meter’s software design and to the instructions given to users.

What Class I means

The FDA uses Class I when there is a reasonable chance a product will cause serious health problems or death. It is the most serious of the FDA’s three recall classes.

A Class I recall does not always mean a product is removed. This one is a correction. Trividia first sent customers updated instructions on February 6, 2026. It sent an updated notice on May 1, 2026. The FDA’s recall database lists the recall as open.

The FDA does not tell users to stop testing right away. It recommends switching to another testing method when possible, and continuing to test until one is available.

The reported injuries and death

The FDA says that as of January 16, 2026, Trividia had reported 114 serious injuries and one death associated with this issue. That number is tied to that date. It may have changed since.

These are reports made to the FDA. They are not findings that the meter caused each injury, and they are not results of any lawsuit. Whether a person has a legal claim depends on the facts of what happened, the records and the law that applies.

Is there a lawsuit or settlement?

As of September 25, 2026, we have not found a public settlement, jury verdict or class action about the E-5 issue in the federal court records we reviewed. A recall does not guarantee a lawsuit or a payment.

You can read more about the TRUE METRIX glucose monitor recall, including which meters are included and what information may help if someone was seriously harmed.

TRUE METRIX meters are not the only glucose monitors with recent FDA notices. Our overview of glucose monitor recalls explains how blood glucose meters differ from continuous glucose monitors and links to each recall.

This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.

Sources and citations

Statutes, regulations, agency material and decisions referred to above.

  1. Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety CommunicationU.S. Food and Drug AdministrationApril 28, 2026; updated May 19, 2026. Source of the E-5 problem, the possible harms, the injury and death count as of January 16, 2026, and the FDA’s recommendations.
  2. Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring SystemsU.S. Food and Drug AdministrationContent current as of May 19, 2026. Source of the affected systems, the cobranded products, the Class I classification and the dates of Trividia’s letters.
  3. Medical Device Recall Z-1545-2026 — TRUE METRIX Self-Monitoring Blood Glucose SystemU.S. Food and Drug AdministrationInitiated February 6, 2026. Source of the open recall status and the cause listed as software design. Checked September 25, 2026.
  4. What Is a Medical Device Recall?U.S. Food and Drug AdministrationSource of the meaning of Class I and of a correction.

Vetted by

Stefan Rest, managing director of CBW Law

Stefan Rest

Managing Director, CBW Law

Stefan Rest has spent more than two decades advocating for consumers and helping people understand how the law may provide a path forward when they’ve been wronged. As Managing Director of CBW Law, he oversees client relations, the firm’s national law-firm network and new partnerships. He writes about developing litigation and consumer legal issues because the right information can help people recognize when their own story may matter.

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