On February 6, 2026, Trividia Health began a recall, carried out as a labeling correction, of every TRUE METRIX blood glucose meter it sold, store brands included.[3][2] On March 12 the FDA classified it as Class I, its most serious recall type.[3][2] The agency followed with a safety communication on April 28, 2026.[1]
Why the meters were recalled
The problem was one error code. TRUE METRIX meters showed E-5 both for a very high blood glucose result (above 600 mg/dL) and for a test strip error.[2] The FDA's enforcement record says the owner's booklets and online labeling did not give lay users adequate directions to act on E-5 or make clear that it could mean very high glucose.[3]
That confusion could hurt someone. The FDA wrote that a user who took a high-glucose E-5 for a strip error could delay treatment. A user who wrongly assumed E-5 meant high glucose could treat a high level they didn't have.[1] As of January 16, 2026, Trividia had reported 114 serious injuries and one death associated with the issue.[1]
The recall covers three self-monitoring systems (TRUE METRIX, TRUE METRIX AIR and TRUE METRIX GO) plus the TRUE METRIX PRO professional system.[2] The enforcement record lists 12,067,458 units, sold in the United States, Puerto Rico and five other countries.[3]
What the FDA and Trividia told users
The FDA's April 28 communication recommended that all TRUE METRIX users move to another way of testing blood glucose when possible, and keep using their meter until they had one.[1] Anyone who sees E-5 while having symptoms of low or high blood glucose should contact their health care provider right away, the agency said.[1] Its own recommendations had not changed when it posted Trividia's updated correction notice on May 19, 2026.[1]
Trividia's notice offered people with diabetes a free TRUENESS meter and test strips through its Customer Support Department. It also said TRUE METRIX products were not to be returned.[4]
What happened next
On July 23, 2026, the FDA cleared a Special 510(k), K262116, for the TRUE METRIX Self Monitoring Blood Glucose System.[5] Here's what we found in the FDA's decision summary: strip errors caused by very high glucose (above 900 mg/dL) moved from E-5 to a new "EHi" code, with labeling updated to match.[6]
Trividia's updated notice said the upgraded TRUE METRIX self-monitoring system was expected at most retail pharmacies beginning in September 2026.[4] It added that it was still working with the FDA on the AIR, GO and PRO meters.[4] When we checked openFDA on October 15, 2026, the recall was still listed as ongoing.[3]
How to check your lot number
You don't need a lot number for this one. Every TRUE METRIX model is covered, so the only question is whether your meter is one of them.[2]
Start with the name. The FDA notes that affected meters may carry a store or distributor brand.[1] Trividia's notice lists those cobranded names, among them CVS, Walgreens, Kroger, Relion (Walmart) and Good Neighbor Pharmacy.[4] The FDA's full list of affected products pairs each store name with TRUE METRIX, as in "Walgreens TRUE METRIX Kit." It also gives the UPC for most packages, so you can match it against the barcode number on your box.[7]
Then turn the meter over. Trividia says the serial number (SN) is printed on the back of TRUE METRIX, AIR and GO meters.[4] Affected serial numbers start with the letter "T" followed by eight digits, according to the enforcement record.[3]
What this means for you
Both the FDA and Trividia said the recall applies to all four TRUE METRIX models, including store-brand versions.[1][4] US patients with questions can reach Trividia at 1-888-835-2723 or [email protected], the FDA recall page says.[2] Trividia's customer care line is 1-888-943-2387, weekdays from 8 a.m. to 8 p.m. ET.[4] The FDA asked users to report problems with these meters to both the FDA and Trividia.[1]
Talk to your care team or pharmacist.
References
- U.S. Food and Drug Administration. Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety CommunicationSource
- U.S. Food and Drug Administration. Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring SystemsSource
- U.S. Food and Drug Administration. openFDA device enforcement report: recall Z-1545-2026 (Trividia Health, Inc.)Source
- Trividia Health. E-5 Product Notice: Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring SystemsSource
- U.S. Food and Drug Administration. 510(k) Premarket Notification K262116: TRUE METRIX Self Monitoring Blood Glucose SystemSource
- U.S. Food and Drug Administration. Special 510(k) Substantial Equivalence Determination Decision Summary, K262116Source
- U.S. Food and Drug Administration. List of Impacted Products: Trividia Health TRUE METRIX Blood Glucose Monitoring SystemsSource