BEUDAMED
    FDA Recall Terminated

    Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

    Recall: Z-0843-05 · Initiated March 7, 2005

    Recall

    Recall Number
    Z-0843-05
    Event Number
    31482
    Firm
    BIOMERIEUX, INC.
    FEI Number
    3002769706
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2005
    Posted
    May 18, 2005
    Terminated
    October 16, 2006
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

    Reason

    The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.

    Action

    Consignees were notified by letter on/about March 7, 2005.

    Distribution

    Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand

    Quantity

    19748 kits