BEUDAMED
    FDA Enforcement Class II Terminated

    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.

    Recall: Z-0330-2017 · Reported November 9, 2016

    Enforcement

    Recall Number
    Z-0330-2017
    Event ID
    75066
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Azer Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    November 9, 2016
    Initiation Date
    August 24, 2016
    Classification Date
    November 2, 2016
    Termination Date
    October 6, 2017
    Address
    701 Hemlock Rd, Morgantown, PA, 19543-9768, United States

    Description

    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.

    Reason

    Out of Specification Microbiological test results

    Code Info

    Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017

    Distribution

    Nationwide Distribution

    Quantity

    1,141 Cases