Trividia Health recalled 1,001,534 TRUE METRIX PRO owner’s booklets used with glucose meters distributed worldwide through multiple retailers. The labeling fails to clearly warn that an E-5 error could indicate very high blood glucose and does not emphasize immediate actions. Consumers should stop using the device and follow manufacturer recall instructions by letter, contacting Trividia Health or
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Trividia Health, Inc. or your healthcare provider for instructions. Notification method: Letter
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TRUE METRIX PRO is a blood glucose measurement device used by patients to monitor glucose levels. The recall concerns the owner’s booklet and instructions for use supplied with these devices.
The labeling does not clearly communicate that the E-5 error could reflect a dangerously high glucose level or the immediate actions required. This ambiguity could delay medical care for patients experiencing high glucose symptoms.
This recall is not described as part of a broader industry safety pattern.
Consumers may face delays in treatment if they misinterpret E-5 errors and fail to seek medical attention promptly.
Owner’s Booklet/IFU for TRUE METRIX PRO devices; model numbers listed above.
Timeline for refunds or replacements not specified in available material.
Save recall notices, communications, and any correspondence with the manufacturer. Photograph the device labeling and store proof of purchase if available.
Model numbers: RE4H01P-40, RE4H01P-43, RE4212P-00, RE4099P-40, RE4099P-43, RE4051P-00, RE4068P-01, RE4TVHP03 Rev 56, RE4SUNP03 Rev 56. Where sold: Worldwide distribution including US, Puerto Rico, Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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