BEUDAMED
    FDA Recall Terminated

    MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    Recall: Z-0053-05 · Initiated August 20, 2004

    Recall

    Recall Number
    Z-0053-05
    Event Number
    30013
    Firm
    bioMerieux
    FEI Number
    3002769706
    Product Code
    GJA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2004
    Posted
    October 28, 2004
    Terminated
    June 9, 2005
    Address
    100 Rodolphe St, Bldg 1300, Durham, NC, 27712-9402

    Description

    MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    Reason

    Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

    Action

    Consignees were notified by letter on 8/20/2004.

    Distribution

    Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK

    Quantity

    1165 units