Trividia Health recalls owner booklets and instructions 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 certain blood glucose meters because the labeling doesn't clearly explain what to do when they show an E-5 error code. This could delay treatment if users don't seek medical help immediately when experiencing high blood glucose symptoms.
The E-5 error code on these meters can indicate very high blood glucose levels. The current labeling doesn't clearly state that users should contact a healthcare professional immediately if they see this error and have symptoms of high blood sugar, which could delay critical treatment.
People who own or use the recalled blood glucose meters with outdated owner booklets or instructions. Those with diabetes who rely on these meters are most at risk.
Check for the following: Owner's Booklets or Instructions for Use (IFUs) with model numbers like RF4001-01BK, RF4007-01, or RF4019-01. The product was sold at stores like Walgreens, CVS, Meijer, and Rite Aid. The owner booklets have revisions 51 or older.
If your blood glucose meter shows an E-5 error code and you have symptoms of high blood sugar, contact a healthcare professional immediately.
Replace outdated owner booklets or instructions with the latest versions from Trividia Health.
The E-5 error code on these blood glucose meters can indicate very high blood glucose levels, which requires immediate medical attention.
Check your blood glucose meter's model number on the packaging or owner booklet. The recalled products include models like RF4001-01BK, RF4007-01, and RF4019-01, sold at stores such as Walgreens and CVS.
No, you can continue using the device but you must follow updated instructions for the E-5 error code to avoid delays in treatment.
We’ve drafted a message you can send Trividia Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1548-2026 — Trividia Health Trividia Health Hello, I own a Trividia Health that is covered by recall Z-1548-2026 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.