FDA ties TRUE METRIX Safety Communication to Class I recall update

FDA has linked a Medical Device Safety Communication on TRUE METRIX blood glucose monitoring systems (Trividia Health, Inc.) to an FDA Class I recall update, creating immediate device-vigilance triage needs for teams handling complaints, MDR assessment, and customer guidance.

The FDA Safety Communication is dated April 28, 2026 and alerts consumers and health care providers to risks associated with the use of TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health. In the same communication, FDA states that Trividia Health has issued a recall that affects all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO self-monitoring blood glucose systems, as well as the TRUE METRIX PRO professional monitoring blood glucose system. Importantly for vigilance operations and product identification, FDA notes the scope includes cobranded products sold under store or distribution partner names (collectively referred to as TRUE METRIX in the FDA communication).

FDA’s related Medical Device Recalls and Early Alerts page frames the issue as a Class I recall (the most serious type) and describes the recall communication as an update to an Early Alert. In the “Timeline of Communication Updates,” FDA lists an April 28, 2026 update stating that FDA’s current recommendations can be found in the Safety Communication and noting that the issue has been classified as a Class I recall.

FDA subsequently updated the Safety Communication page on May 19, 2026. FDA’s update notes that on May 1 Trividia Health issued an updated Urgent Medical Device Correction notice, and FDA stated its recommendations for patients and caregivers had not changed.

What PV/device-vigilance teams may want to focus on next is operational alignment to the FDA’s framing: the Safety Communication is explicitly positioned as the source of FDA’s “current recommendations,” while the recall is identified as Class I. For organizations connected to these products—particularly those distributing or supporting cobranded/store-brand variants—this linkage can drive near-term needs to confirm whether complaint intake and MDR screening are capturing the full product scope and whether event coding and investigation conclusions remain consistent with the issue described by FDA.

Within mapped workflows, this may translate into an immediate case-finding and trending exercise for TRUE METRIX (including partner/store-brand identifiers) and a check that customer-facing materials (call-center scripts, distributor communications, and HCP messaging) are consistent with FDA’s current recommendations and the company’s Urgent Medical Device Correction updates referenced by FDA.

Given the fact sheet does not include the specific hazard/failure mode(s) or detailed FDA recommendations, teams should retrieve and review the full FDA Safety Communication and the linked recall/early-alert page to confirm the exact risk statements and the operational recommendations FDA expects stakeholders to follow.

Practical implication: If you distribute, rebrand, or provide support for TRUE METRIX-branded or cobranded meters, consider initiating immediate complaint/MDR case finding and ensuring scripts and escalation paths reflect the FDA Safety Communication referenced in the Class I recall update, while monitoring the FDA pages at least weekly until stable.