Trividia Health recalled 3,678,026 TRUE METRIX AIR owner’s booklets distributed worldwide through Walgreens, CVS and other retailers. The recall centers on labeling for the E-5 error code, which could indicate very high blood glucose and lacks clear, immediate action guidance. Consumers should stop using the device and await manufacturer instructions mailed to customers.
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 AIR is a blood glucose monitoring system used to measure blood sugar levels. The recall concerns owner’s booklets and the labeling that accompany the device across multiple retailers and markets.
The labeling for the E-5 error code does not clearly indicate that it could reflect very high blood glucose. It also does not prominently convey the appropriate immediate actions, such as seeking medical help. This gap could delay treatment in symptomatic individuals.
This recall is not described as part of a broader industry pattern.
Consumers may experience delays in recognizing dangerous hyperglycemia. The recall indicates a potential for life-threatening consequences if high glucose is not treated promptly.
Recall notices and labeling updates are issued by Trividia Health. Additional details are on the FDA enforcement page linked in the recall notice.
Timeline for refunds or replacements is not specified in the recall.
Keep the recall notice, note dates of contact with the manufacturer, and save all related correspondence and packaging.
Models/UDI-DI: REA4001-01/311917173894; REA4002-01/96295129267; REA4007-01/50428354766; REA4011-01/87701427398; REA4019-01/708820685659; REA4020-01/41415072787; REA4025-01/93351022784; REA4031-01/41220009169; REA4054-01/10939742445; REA4066-01/11822590051; REA4081-01/21292015015; REA4081-40/21292007164; REA4081-43/21292007584; REA4089-01/52569139042; REA4094-01/681131240154; REA4094-01RX/681131403214; REA4203-01/41260007354; REA4211-01/10939958617; REA4H01-01/21292007010; REA4H01-40/21292007447 Sold at: Worldwide distribution including US nationwide including Puerto Rico and the countries of:
No injuries or incidents have been reported.
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