BEUDAMED
    FDA Recall Terminated

    Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico).

    Recall: Z-0931-2008 · Initiated December 21, 2007

    Recall

    Recall Number
    Z-0931-2008
    Event Number
    46207
    Firm
    Bayer Healthcare LLC
    FEI Number
    1826988
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 21, 2007
    Posted
    March 13, 2008
    Terminated
    July 7, 2009
    Address
    430 S Beiger Street, Mishawaka, IN, 46544-3207

    Description

    Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico).

    Reason

    InaccurateTest Strip Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

    Action

    The firm issued a Press Release on 12/21/07. A Test Strip Recall letter was also sent to the firm's consignees and health care providers instructing them that use of the product should cease and that health care providers contact the firm for replacements. Additional information can be found at www.bayerdiabeties.com or by contacting the Bayer at 1-800-348-8100.

    Distribution

    Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.

    Quantity

    97,000 bottles of test strips