BEUDAMED
    FDA Recall Terminated

    BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704

    Recall: Z-0628-03 · Initiated December 23, 2002

    Recall

    Recall Number
    Z-0628-03
    Event Number
    25366
    Firm
    Biomerieux, Inc.
    FEI Number
    1039284
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2002
    Posted
    March 6, 2003
    Terminated
    January 21, 2004
    Address
    100 Rodolphe Street, Durham, NC, 27712

    Description

    BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704

    Reason

    Vial to vial variability which can result in prolonged clot times.

    Action

    Consignees were notified by letter via regular mail on December 23, 2002. They were advised to cease using the product, pull affected lot numbers, destroy the material and contact bioMerieux for replacement. Expanded recall 3/18/2003, consignees were notified by letter on March 19th , and March 31, 2003. Consignees were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

    Distribution

    CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved.

    Quantity

    4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,280 kits of lot 161662.