Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
Recall
- Recall Number
- Z-1548-2026
- Event Number
- 98317
- Firm
- Trividia Health, Inc.
- FEI Number
- 1000113657
- Product Code
- NBW
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- February 6, 2026
- Posted
- March 12, 2026
- Address
- 3230 W Prospect Rd, Fort Lauderdale, FL, 33309-2592
Description
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
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 [email protected] 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 [email protected] or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press.
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
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