BEUDAMED
    FDA Recall Terminated

    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.

    Recall: Z-0784-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0784-05
    Event Number
    31710
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LIP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    April 28, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.

    Reason

    Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.

    Action

    Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers.

    Distribution

    MA, CA, TX, KS, NY, FL

    Quantity

    14 kits