BEUDAMED
    FDA Enforcement Class II Terminated

    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.

    Recall: Z-2482-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2482-2015
    Event ID
    71611
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    June 22, 2015
    Classification Date
    August 28, 2015
    Termination Date
    May 23, 2016
    Address
    430 S Beiger St, N/A, Mishawaka, IN, 46544-3207, United States

    Description

    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.

    Reason

    If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.

    Code Info

    SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots

    Distribution

    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.

    Quantity

    5 million bottles of control solution