Trividia Health's TRUE METRIX GO blood glucose kits sold at Walgreens, CVS and other retailers are recalled worldwide. The labeling fails to clearly emphasize that an E-5 error could indicate very high blood glucose and require immediate action. Consumers should stop using the device and follow manufacturer guidance.
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 GO is a blood glucose monitoring system used to measure blood sugar levels. It is distributed through multiple retailers worldwide and includes owner’s booklets and instructions.
Labeling failed to clearly emphasize that E-5 could indicate dangerously high blood glucose and did not prominently instruct immediate action. This may delay treatment during high glucose events.
This recall is not described as part of a broader industry pattern.
Consumers may experience delays in recognizing dangerous hyperglycemia. The recall emphasizes consuming urgent action rather than relying on ambiguous labeling.
Look for the model numbers in the device, its owner’s booklet or Instructions for Use. International variants have separate RF codes.
Recall actions typically complete within 4-8 weeks for replacements or updated labeling.
Keep the recall notification, model numbers, photos of labels and manuals, and all email/phone correspondences with the manufacturer.
Model numbers and related items include RF4001-01BK, RF4007-01, RF4019-01, RF4023-01, RF4031-01, RF4048-01, RF4066-01, RF4209-01, RF4H01-01BK, RF4H01-40, RF4i29-11BK, RF4i81-11BK, RF4i82-11BK, RF4i82-12BK, RF4TVH03 Rev 57 and prior, RF4TVH35 Rev 51 and prior, RF4ITV16 Rev 55 and prior, RF4UKT16 Rev 56 and prior, RF4LAT16 Rev 51 and prior, RF4AUT16 Rev 57 and prior. Description covers Owner’s Booklets and Instructions for Use used with TRUE METRIX GO kits sold worldwide. Distribution: 1,407,465 units.
No injuries or incidents have been reported.
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