FDA warns TRUE METRIX users to switch glucose meters if possible after Class I recall tied to E-5 error code confusion

The FDA is warning people who use TRUE METRIX blood glucose meters that an E-5 error code can be misleading. In some cases, it may signal a very high blood sugar reading. In others, it may reflect a test strip error.

That matters because the wrong interpretation can delay treatment or lead someone to treat the wrong problem. The FDA says users should find an alternative way to test their blood sugar if possible, but should not stop using their meter until another method is available.

What the recall covers

The FDA says Trividia Health’s recall affects TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO systems, including co-branded versions sold under store or distributor names. The agency classified the recall as Class I, its most serious recall category, because the issue could lead to serious harm.

According to the FDA, the problem is tied to the software design of the E-5 error code and to instructions in the user manuals and online help guides. The meters can show the same E-5 code for two different situations: a very high glucose event above 600 mg/dL, or a test strip error.

Why the issue matters

If a person with very high blood sugar assumes the code is only a strip problem, they may delay getting help. If someone with low or normal blood sugar assumes the code means a dangerous high, they may treat themselves for high blood sugar when that is not the issue.

The FDA says either kind of mistake can lead to serious health consequences, including dehydration, altered mental status, loss of consciousness, or death. As of January 16, 2026, Trividia Health had reported 114 serious injuries and one death tied to the issue, according to the FDA.

Who may be at highest risk

The FDA says the concern is especially important for people who use intensive insulin therapy, sulfonylureas, or who have frequent high and low blood sugar events. Those readers may have less room for delay or confusion when a meter gives an unclear result.

Families and caregivers should also pay attention if they help someone who checks blood sugar at home, especially if that person has had repeated highs or lows or may not always recognize symptoms early.

What the FDA says to do now

The FDA recommends that TRUE METRIX users seek an alternative glucose testing method if possible. People should continue testing and should not stop using their current meter until a backup option is in place.

The agency also says users should talk with a health care provider or pharmacist about switching options, and that health care providers should notify affected patients and help them transition to another testing method.

What to do if you see an E-5 code

If a user gets an E-5 code while also having symptoms of low or high blood sugar, the FDA says they should contact a health care provider right away for help deciding what to do next.

Until a backup testing method is available, the practical step is to know your meter model, keep extra supplies on hand if possible, and review the updated instructions for what the E-5 code may mean.

When to seek urgent help

The CDC says low blood sugar below 70 mg/dL is considered low and can be dangerous if left untreated. Common symptoms include shaking, sweating, dizziness, hunger, irritability, confusion, and a fast heartbeat.

The CDC says more serious low blood sugar can cause weakness, trouble walking or seeing clearly, strange behavior, confusion, or seizures. If someone cannot safely treat a severe low or is not waking up, emergency care is needed.

Low blood sugar basics

For context, the CDC recommends the 15-15 rule for low blood sugar: take 15 grams of fast-acting carbohydrate, wait 15 minutes, then check again. Repeat if blood sugar is still below 70 mg/dL. Afterward, eat a balanced snack or meal with protein and carbs.

The CDC also says severe low blood sugar may require injectable glucagon and emergency medical treatment. Friends, family members, teachers, coworkers, and caregivers may benefit from knowing where a glucagon kit is kept and how to use it.

Bottom line for families and caregivers

If you or someone you care for uses a TRUE METRIX meter, check the model and look for any recall updates from the manufacturer or FDA. If possible, arrange a backup way to test blood sugar now rather than waiting for a problem to happen.

The main public-health message is simple: do not ignore an E-5 code, but also do not assume it always means the same thing. Until the recall is corrected, that code can point to two very different situations, and the difference matters.

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.