Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

On 2/6/2026, press was issued and correction notices were emailed to customers. The E-5 Error Code in the Messages section of the Owner's Booklets/System Instructions for Use emphasizes that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Firm will notify users of additional mitigation strategies as needed. Customers: notify your customers immediately of the correction and to include the letter in their notification, and to ask that they notify their customers or facilities if they have further distributed the Products. Retail pharmacies: post the notice in areas where the Products are sold to notify patients. Multiple Patient Facilities: post the notice provided in areas where the Products are stored within your facility to notify personnel of this labeling correction. People with Diabetes are asked to follow the updated E-5 error code instructions in the notice or visit www.trividiahealth.com for links to the updated Owner's Booklets and help resources. Complete and return the acknowledgement form via email to trividia0126CS@trividiahealth.com If you have any questions, please call Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press.

• FDA enforcement recordOfficial FDA database entry for Z-1546-2026
• FDA 510(k) clearance · K140100The device's official FDA premarket clearance record
• FDA device classification · NBWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1345The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Trividia Health, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.