BEUDAMED
    FDA Recall Terminated

    Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;

    Recall: Z-0709-2007 · Initiated December 18, 2006

    Recall

    Recall Number
    Z-0709-2007
    Event Number
    37385
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2006
    Posted
    May 23, 2007
    Terminated
    December 20, 2010
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000

    Description

    Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;

    Reason

    If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.

    Action

    Firm initiated its recall on 12/21/2006. The firm provided customer letters with additional information (eg. flyer or insert) to customers that they had addresses for via fedex. In addition, the product notification was posted on the firm's internet website. Further, a flyer is to be included as a supplement to the user manual.

    Distribution

    Worldwide Distribution: USA as well as abroad to Argentina, Aruba, Australia, Austria, Bahamas, Belgium, Canada, Colombia, Croatia, Curacao, Czech/Slovak Republics, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Latvia, Lithuania/Estonia (Baltics), Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Portugal, Saudi Arabia, Serbia, Bulgaria/Macedonia, Singapore, Slovenia, South Africa, Spain, St. Maarten, Sweden, Switzerland, Turkey, UK and Venezuela.

    Quantity

    67,601 units