Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/

FDA device recall Z-1545-2026 · posted 2026-03-12 · Open, Classified

Recall details

Recalling firm

Trividia Health, Inc.

Reason for recall

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.

Action taken

On 2/6/2026, press was issued and correction notices were emailed to customers. 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. 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 in areas where the Products are stored to notify personnel. People with Diabetes are asked to follow the updated E-5 error code instructions Visit www.trividiahealth.com for updated Owner's Booklets and help resources. Complete and return the acknowledgement form via email to trividia0126CS@trividiahealth.com Firm Customer Care Department: 1-888-835-2723, trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press. On 5/5/2026, updated correction notices were mailed to customers informing them of the following: For people with diabetes, if possible, consider transitioning to an alternative method of testing your blood glucose. People with Diabetes who rely on intensive insulin therapy, sulfonylureas, or glucose monitoring due to frequent hypo- or hyperglycemia events should consider transitioning to an alternative testing method until the updated devices with updated software becomes available. Firm will notify users when the upgrade program becomes available. The firm asked customers to handle dissemination of the updated notice and completion/return of the acknowledgement form as stated above. Affected serial number search tool is located at www.trividiahealth.com/E-5productnotice

Root cause

Software design

Status

Open, Classified

Product code

NBW

Quantity affected

12,067,458

Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.

Date initiated

2026-02-06

Date posted

2026-03-12

Location

Fort Lauderdale, FL

Related 510(k) clearances