BEUDAMED
    FDA Recall Terminated

    The MDA system with MDA Antithrombin III MDA Heparin

    Recall: Z-0043-05 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-0043-05
    Event Number
    30026
    Firm
    bioMerieux
    FEI Number
    3002769706
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    October 23, 2004
    Terminated
    June 7, 2005
    Address
    100 Rodolphe St, Bldg 1300, Durham, NC, 27712-9402

    Description

    The MDA system with MDA Antithrombin III MDA Heparin

    Reason

    The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.

    Action

    Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.

    Distribution

    Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK