Trividia Health recalls blood glucose meters with outdated user manuals that don't clearly explain E-5 error code risks, which could delay treatment for high blood glucose levels.
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.
Trividia Health is recalling owner booklets and instructions for use that come with certain blood glucose meters. These materials don't clearly explain what to do when the E-5 error code appears, which could delay medical treatment if the user has high blood glucose levels.
The user manuals don't clearly state that an E-5 error code indicates very high blood glucose levels or provide immediate steps to take, like contacting a healthcare provider. This could cause delays in treatment if the user experiences symptoms of high blood glucose and doesn't act quickly.
People who own or use the recalled blood glucose meters with outdated owner booklets or instructions. Those with diabetes who rely on these meters for monitoring are most at risk.
Check for the following: Owner's Booklets or Instructions for Use with model numbers RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, or RE4068P-01. The product serial numbers start with 'TP' followed by seven digits.
Check if your owner's booklet or instructions for use have a revision number of 56 or earlier for the specified models.
The recall does not require stopping use; the issue is with the instructions, not the device itself.
The recall states that the instructions don't clearly explain this error code, so contact a healthcare professional immediately if you experience symptoms of high blood glucose.
The affected meters include the TRUE METRIX PRO Meter and Starter Kit with specific model numbers and serial prefixes.
We’ve drafted a message you can send Trividia Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1546-2026 — Trividia Health Trividia Health Hello, I own a Trividia Health that is covered by recall Z-1546-2026 from Trividia Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
