BEUDAMED
    FDA Recall 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 · Initiated June 22, 2015

    Recall

    Recall Number
    Z-2482-2015
    Event Number
    71611
    Firm
    Bayer Healthcare, LLC
    FEI Number
    1826988
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 22, 2015
    Posted
    August 29, 2015
    Terminated
    May 23, 2016
    Address
    430 S Beiger St, Mishawaka, IN, 46544-3207

    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.

    Action

    On 6/22/2015, Bayer Healthcare began sending URGENT - MEDICAL DEVICE FIELD CORRECTIVE ACTION notifications to affected Health Care Providers, Pharmacies, and Users. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are instructed to always check the expiration, not to use and discard of expired control solutions. Also, only CONTOUR NEXT control solution should be used with the CONTOUR NEXT test strips. The control solution bottle should be shaken about 15 times before each use. The letter instructed customers to refer to their meter's user guide for further testing instructions. If test results outside the control range are received, another test should be performed following the instructions provided in the letter. If the problem persists, customers should contact Bayer Diabetes Support. Bayer will replace the control solution or provide new control ranges for the test strips, depending on the situation. The firm has implemented improvements to provide more consistent control solution product.

    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