BEUDAMED
    FDA Recall Terminated

    Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223

    Recall: Z-0289-06 · Initiated June 4, 2004

    Recall

    Recall Number
    Z-0289-06
    Event Number
    34055
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    DIO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2004
    Posted
    December 15, 2005
    Terminated
    April 14, 2006
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223

    Reason

    The device was producing false negative results for cocaine tests.

    Action

    Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed.

    Distribution

    60 consignees received the product in the US and 6 international consignees received the product. Distribution is limited to the following countries: Canada, France, UK, Germany and Italy.

    Quantity

    384 units