Recall Z-1545-2026 ยท NBW System, Test, Blood Glucose, Over The Counter
Trividia Health, Inc.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/
| Date | Mar 12, 2026 (initiated Feb 6, 2026) |
| Status | Open, Classified |
| Reason | 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 glu |
| Root cause | Software design |
| Action | 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 Product |
| Quantity | 12,067,458 |
| Distribution | Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM Nipro Diagnostics, Inc., Aug 1, 2014 |