Trividia Health recalls owner booklets for blood glucose meters that don't clearly explain E-5 error code actions, risking delayed treatment for high blood sugar.
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 tell users what to do when they see an E-5 error code, which could mean very high blood glucose levels. If users ignore symptoms and don't seek medical help immediately, they might delay treatment.
The owner booklets and instructions don't clearly explain that an E-5 error code might indicate very high blood glucose levels. They also don't emphasize the need to contact a healthcare professional immediately if symptoms of high glucose occur. This could lead to delayed treatment if users don't act quickly.
People who own or use blood glucose meters with the recalled owner booklets and instructions. Those with diabetes who rely on these devices for monitoring are most at risk.
Check if your blood glucose meter has a model number starting with RE4001-01, RE4002-01, or similar codes listed in the recall. The owner booklets or instructions are versions RE4TVH03 Rev 56 and prior, or RE4TVH35 Rev 51 and prior.
Check your owner booklet or instructions for clear guidance on E-5 error code actions, especially if you see symptoms of high blood glucose.
If you receive an E-5 error code and have symptoms of high blood glucose, contact a healthcare professional immediately.
The E-5 error code on blood glucose meters, which may indicate very high blood glucose levels.
No, but you should follow the instructions in the owner booklet if you see an E-5 error code and have symptoms of high blood glucose.
Check your blood glucose meter's model number against the list of affected codes in the recall notice.
We’ve drafted a message you can send Trividia Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2026 — Trividia Health Trividia Health Hello, I own a Trividia Health that is covered by recall Z-1545-2026 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.
