BEUDAMED
    FDA Recall Terminated

    Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    Recall: Z-0448-2007 · Initiated August 24, 2006

    Recall

    Recall Number
    Z-0448-2007
    Event Number
    36706
    Firm
    Drew Scientific Group PLC
    FEI Number
    3003071743
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2006
    Posted
    January 9, 2007
    Terminated
    March 10, 2008
    Address
    4230 Shilling Way, Dallas, TX, 75237-1023

    Description

    Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    Reason

    Flags and alerts on the user interface will not automatically transfering to the LIS.

    Action

    Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available

    Distribution

    Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.-

    Quantity

    545 units.