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.
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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Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.. Reason: 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.. Classification: Class I. Quantity: 12,067,458. Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
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