BEUDAMED
    FDA Enforcement Class II Terminated

    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.

    Recall: Z-1587-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1587-2016
    Event ID
    73486
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Livongo Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    February 18, 2016
    Classification Date
    April 29, 2016
    Termination Date
    March 6, 2018
    Address
    444 N Michigan Ave Ste 2880, Chicago, IL, 60611-3998, United States

    Description

    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.

    Reason

    The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acid

    Code Info

    Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.

    Distribution

    US consignees: Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington.

    Quantity

    63,000 units