True Metrix Blood Glucose Monitoring Systems: The E-5 Error Code, the 2026 Class I Recall, and What Patients Need to Know

June 02, 20269 minute read

Published by Justpoint Inc.

If you use a True Metrix, True Metrix Air, True Metrix Go, or True Metrix Pro blood glucose meter to manage diabetes, you need to know about a labeling defect the U.S. Food and Drug Administration has classified as a Class I recall — the agency’s most serious recall category, reserved for problems that could cause serious injury or death.

The defect does not affect the meter’s ability to measure glucose levels accurately when it is used as intended. The True Metrix meters meet the international accuracy standard for glucose meters when used as instructed. The defect is in how the device communicates a critical reading: when your blood sugar is above the clinical threshold for hyperglycemic emergency — 600 mg/dL — the meter does not show the number. It shows an error code, “E-5.” Because the device shows the same E-5 code when there is a test-strip problem, a user looking at the screen cannot tell whether the meter is reporting a hardware fault or a hyperglycemic emergency requiring urgent care.

As of January 16, 2026, 114 serious injuries and one death have been reported in association with the E-5 labeling issue, per the FDA Safety Communication and Trividia Health’s adverse-event reporting. These figures come from manufacturer adverse-event reporting (MAUDE-style passive surveillance) and reflect reported associations subject to reporting bias; they do not establish device-level causation for any individual case. In February 2026, Trividia issued a labeling correction. In April 2026, the FDA followed with a Safety Communication recommending that all True Metrix users transition to an alternative blood glucose monitoring system when possible.

This article explains what the True Metrix line of devices is, what the E-5 error code actually means, how the recall affects you, how to verify whether your meter is reliable, what warning signs to watch for, and what to do if you have been harmed.

What the True Metrix product line is

True Metrix is a family of self-monitoring blood glucose (SMBG) systems made by Trividia Health, Inc. (Fort Lauderdale, Florida), the successor to Home Diagnostics. The product line includes four meters that share the same test-strip chemistry and the same error-code logic:

True Metrix — the base, non-connected meter for daily home use. Cleared under 510(k) K120989 and K140100.
True Metrix Air — the Bluetooth-enabled version that syncs readings to a smartphone app.
True Metrix Go — a compact, lower-cost meter cleared in 2016 under 510(k) K143548.
True Metrix Pro — the professional-use version for clinics and pharmacies.

All four meters use the same True Metrix test strips and the same internal firmware that drives the E-5 error code. Trividia distributes the devices in the United States, the United Kingdom, Mexico, Australia, and parts of the Caribbean — and also sells them under pharmacy store brands and private-label distribution partners, meaning a store-brand meter may still be a True Metrix underneath.

The FDA classifies these devices as Class II (“System, Test, Blood Glucose, Over the Counter”) under product code NBW — a moderate-risk classification reviewed through the 510(k) pathway.

What ISO 15197:2013 means and why it matters here

Every blood glucose meter sold in the U.S. is expected to meet the ISO 15197:2013 standard — the international rule for SMBG accuracy. Under this standard, at least 95% of readings must fall within ±15 mg/dL of a laboratory reference at glucose concentrations below 100 mg/dL, or within ±15% at glucose concentrations of 100 mg/dL or higher. 99% of readings must fall in clinically reasonable zones of a Parkes (Consensus) Error Grid.

Trividia’s published clinical validation reports for the True Metrix, True Metrix Air, and True Metrix Go systems indicate that the devices meet the ISO 15197:2013 thresholds. This validation was performed by the manufacturer; sponsor-funded validation studies may be subject to selection bias and should be interpreted accordingly. This is important context: the FDA’s 2026 Class I recall is not about the meter giving you a wrong number. The meter, when it gives a number, is generally within the ISO 15197 limits. The recall is about what the meter does instead of giving you a number — it shows the ambiguous E-5 code at the precise moment your readings matter most.

The E-5 error: the safety issue at the center of the recall

When the blood on a True Metrix test strip generates a glucose value above 600 mg/dL, the meter does not display the number “600+” or “HI” — it displays “E-5.” But the meter also displays “E-5” for test-strip-related errors: a damaged, expired, contaminated, or under-filled strip. A patient holding the meter has no way to distinguish:

Scenario A: The strip is bad — discard it, insert a new one, re-test. No emergency.
Scenario B: The blood sugar has crossed into the hyperglycemic-emergency range. This range is considered a medical emergency per clinical guidelines and warrants urgent evaluation.

A glucose value above 600 mg/dL is a defining feature of hyperglycemic hyperosmolar state (HHS) — a serious condition requiring urgent treatment that may lead to dehydration, altered mental status, seizure, coma, or death if untreated. The same range overlaps with severe diabetic ketoacidosis (DKA) in people with type 1 diabetes. Both conditions require urgent hospital treatment with intravenous fluids, electrolytes, and insulin.

If a patient sees “E-5,” assumes a strip error, and tries again — and the next strip also shows “E-5” — the natural conclusion is that the meter or the strips are broken. The patient may not recognize that what the meter is actually saying is: your blood sugar is above 600 mg/dL, and you need to go to the hospital.

The clinical consequences reported to Trividia and the FDA reflect this confusion. The manufacturer has documented 114 serious injuries and one death as of January 16, 2026, with injuries described in the FDA’s communication including dehydration, altered mental status, and loss of consciousness. These figures come from manufacturer adverse-event reporting (MAUDE-style passive surveillance) and reflect reported associations subject to reporting bias; they do not establish device-level causation for any individual case.

The FDA’s 2026 Class I recall and Safety Communication

In February 2026, Trividia Health issued a voluntary medical-device correction (a “labeling correction”) for all True Metrix, True Metrix Air, True Metrix Go, and True Metrix Pro Blood Glucose Monitoring Systems — including cobranded products sold under store-brand names. The correction updates the Owner’s Manual to clarify that the E-5 code can indicate either a strip error or a glucose value above 600 mg/dL, and instructs users to seek urgent medical care if they suspect the latter.

In April 2026, the FDA designated the correction a Class I recall — the agency’s most serious recall category — and issued a Safety Communication titled “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health.” The FDA’s primary recommendation is that users switch to an alternative blood glucose monitoring system when possible, especially patients on intensive insulin therapy, patients taking sulfonylureas (a class of oral diabetes medications that is associated with severe low blood sugar), and patients who have frequent hyperglycemic or hypoglycemic episodes.

The FDA’s communication makes clear: this is not a defect that can be fixed by replacing the strip or recalibrating the meter. The defect is in the device’s design and labeling — the way it communicates critical results. The labeling correction informs users about the ambiguity, but it does not eliminate it. As long as you continue to use a True Metrix meter, an “E-5” code at 601 mg/dL will still look identical to an “E-5” code from a damaged strip.

How to test whether your meter is working correctly

If you continue to use a True Metrix meter while transitioning to an alternative — or if you keep one as a backup — three established methods can confirm the device itself is functioning correctly:

Run a control-solution test. Trividia supplies True Control liquid solutions with a known glucose concentration. Apply a drop to a fresh strip the same way you would apply blood, and confirm the meter reads a value inside the printed range on the test-strip vial. A reading outside the range means the strips, the meter, or the solution has a problem. Trividia recommends a control test every time you open a new vial of strips and any time you suspect a result is wrong.
Compare against a laboratory venous draw. At your next clinic visit, bring your meter and ask the staff to allow you to test a fingerstick at the same moment a venous sample is drawn for the lab analyzer. A correctly functioning True Metrix meter should read within ±15% of the lab value (or within ±15 mg/dL if the value is below 100 mg/dL) — the same ISO 15197:2013 threshold.
Cross-check against a second meter. Run two meters simultaneously on samples from the same fingerstick. If two meters give very different numbers on the same drop, contact your provider; the ISO 15197 accuracy standard compares each meter to a lab reference, not to other meters, so meter-to-meter differences are expected.
If you have questions about your meter’s performance or are unsure how to interpret the results, contact your healthcare provider for assistance.

None of these checks resolve the ambiguity in the E-5 error code. These steps only confirm the meter works when it actually displays a number; they cannot tell if an E-5 code is masking an underlying system failure. The FDA’s recommendation to transition to an alternative meter remains the safest option.

Warning signs of a glucose-monitoring failure

Watch for the following warning signs, which require immediate clinical attention rather than further self-testing:

An E-5 error code accompanied by symptoms of high blood sugar or DKA. General symptoms include extreme thirst, frequent urination, blurred vision, dry mouth, fatigue, and confusion. DKA-specific symptoms include fruity-smelling breath, rapid breathing, abdominal pain, nausea, or vomiting. Experiencing these symptoms alongside an E-5 error requires urgent medical evaluation.
Persistently abnormal meter readings that do not match how you feel —a reading of 90 mg/dL while you are experiencing severe hypoglycemia symptoms (sweating, shakiness, confusion), or a reading of 110 mg/dL while you are drinking water uncontrollably and urinating constantly.
Wide variations between consecutive readings. Noticeably different results taken minutes apart using fresh drops of blood suggest strip or meter inconsistency.
Failed control-solution checks. The control-solution reading consistently falls outside the printed range on the strip vial.
Repeated E-5 codes. Receiving multiple E-5 errors during a single testing session, even after switching to a new strip and a new fingerstick.

When in doubt, do not rely on a questionable meter to decide if you are in an emergency. If your physical symptoms do not match the numbers on the screen, treat the symptoms and seek prompt medical care.

Four pathways to confirm whether your meter is part of the recall

If you are unsure whether your specific meter is affected, the recall covers all True Metrix, True Metrix Air, True Metrix Go, and True Metrix Pro devices distributed in the United States, including cobranded store-brand and distributor versions. Three steps can confirm:

Read the device label. The brand name “True Metrix” (and the specific model — Air, Go, Pro) is printed on the front or back of the meter. If you bought a store-brand glucose meter from a pharmacy chain, the original packaging or the Owner’s Manual will list the underlying manufacturer.
Use the manufacturer’s online recall lookup. Trividia maintains a public information page on the correction at www.trividiahealth.com/E-5productnotice, and a registration site at truemetrixmeters.expertinquiry.com where you can sign up to be contacted. Both pages confirm that the correction applies to all True Metrix-branded meters regardless of lot or serial number.
Call the pharmacy where you purchased the meter. Pharmacies and durable-medical-equipment (DME) suppliers have been notified of the correction and can confirm whether a meter dispensed to you is on the list.
Contact your healthcare provider.

What to do if your meter is failing

If you suspect your meter is unreliable or you have already experienced an E-5 code, take the following steps in order:

If you have symptoms of high blood sugar — extreme thirst, frequent urination, confusion, fruity breath, rapid breathing — seek emergency medical care. Call 911 or have someone drive you to the nearest emergency department.
The FDA recommends transitioning to an alternative blood glucose monitoring system for daily testing. If you do not currently have one, most major pharmacies stock alternative meters (LifeScan OneTouch, Accu-Chek, Contour Next, FreeStyle Lite, Reli On Premier, and others) at over-the-counter prices. Some health plans cover replacement meters during a Class I recall — call your plan to confirm. Discuss the specific choice of replacement meter with your clinician.
Contact Trividia Health customer service about the E-5 issue: 1-888-943-2387 (toll-free), Monday through Friday, 8 AM to 8 PM Eastern Time. Email: [email protected].
Notify your endocrinologist or primary diabetes provider that you are using a meter under Class I recall. Bring the meter to your next visit, and ask whether your treatment plan should be adjusted while you transition to an alternative device. If you have had abnormal readings or E-5 codes, share the dates and circumstances.
Report a problem to the FDA. Patient reports are part of the data the FDA uses to monitor device safety after a recall.

Reporting a problem to the FDA

If you or a family member has experienced harm related to a True Metrix meter — whether through delayed treatment, a hyperglycemic emergency, hospitalization, or any other adverse event — you can file a report directly with the FDA’s MedWatch program:

Online: www.fda.gov/medwatch
Phone: 1-800-FDA-1088 (1-800-332-1088)

MedWatch reports do not initiate a legal claim and are not a substitute for medical care. They do help the FDA track patterns of harm across the device population. Healthcare providers and pharmacists can also submit reports on behalf of patients.

Regulatory context

The True Metrix line was cleared through the FDA’s 510(k) substantial-equivalence pathway, the standard route for Class II in vitro diagnostic devices. Key clearances on the regulatory record include K120989 (TRUE METRIX Self-Monitoring Blood Glucose System and TRUE METRIX PRO), K140100 (TRUE METRIX Self-Monitoring Blood Glucose System), and K143548 (TRUE METRIX GO; commercial launch announced April 2016). The original True Metrix line was launched globally in August 2014. The manufacturer’s reporting of 114 serious injuries and one death tied to the E-5 ambiguity issue forms the evidentiary basis for the FDA’s 2026 Class I recall classification. These figures come from manufacturer adverse-event reporting (MAUDE-style passive surveillance) and reflect reported associations subject to reporting bias; they do not establish device-level causation for any individual case.

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If you are researching this device, these related Justpoint patient guides may also be relevant:

iLet® ACE Pump (Beta Bionics): Safety Alerts, FDA Warning Letter, and What Patients Should Watch For — iLet ACE Pump — another automated insulin-delivery system with safety alerts
Omnipod 5 Pods Recall: Internal Tubing Tear, Insulin Leakage, and What to Do — Omnipod 5 — another automated insulin-delivery pump with a 2026 Class I recall

Sources and how to verify

U.S. Food and Drug Administration — Safety Communication, “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” (April 2026): www.fda.gov/medical-devices/safety-communications/risks-using-true-metrix-blood-glucose-monitoring-systems-trividia-health-fda-safety-communication.
FDA Medical Device Recalls and Early Alerts — “Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems”: www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/blood-glucose-monitor-recall-trividia-health-issues-correction-true-metrix-blood-glucose-monitoring.
FDA 510(k) Premarket Notification Database: searchable at accessdata.fda.gov. Records on file for K120989, K140100, and K143548 list Trividia Health (or its predecessor Home Diagnostics) as applicant; product code NBW; classification “System, Test, Blood Glucose, Over the Counter” (Class II).
FDA Manufacturer and User Facility Device Experience (MAUDE) Database: searchable at accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/. Adverse-event reports for True Metrix, True Metrix Air, True Metrix Go, and True Metrix Pro are filed under product code NBW.
Trividia Health customer notice and product-correction page: www.trividiahealth.com/E-5productnotice and Trividia Customer Support: 1-888-943-2387 (Monday–Friday, 8 AM–8 PM ET). General customer care: 1-888-835-2723. Email: [email protected].
ISO 15197:2013 — In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. International Organization for Standardization. Catalog entry at www.iso.org/standard/54976.html.
Trividia clinical-validation white papers: “Evaluation of Accuracy and User Performance of the TRUE METRIX AIR” and “Clinical Accuracy and User Performance of the TRUE METRIX GO” — published by Trividia Health and distributed through trividiahealth.com.
FDA MedWatch (adverse-event reporting): www.fda.gov/medwatch or 1-800-FDA-1088.

This article was published by Justpoint Inc. The information provided is for educational purposes, does not constitute medical or legal advice and is based on publicly available research and regulatory communications. Findings may vary depending on individual circumstances, device type, and clinical context. If you have a medical device that may be affected, please consult your physician. If you believe you may have a legal claim, please consult a qualified attorney.

Justpoint Inc. supports Justpoint Law (Justpoint PLLC) by providing operational and administrative services. All legal services are provided by Justpoint Law, and any client-related communications are made on its behalf.

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