BEUDAMED
    FDA Recall Terminated

    Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .

    Recall: Z-0636-05 · Initiated January 10, 2005

    Recall

    Recall Number
    Z-0636-05
    Event Number
    31104
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    DFC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 10, 2005
    Posted
    March 18, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .

    Reason

    QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.

    Action

    Customers were sent notification letters and instructed to destroy any remaining inventory. Customers were also requested to return a form which indicates number of kits destroyed and a replacement was offered.

    Distribution

    KC, MO, CA, IN, HI, GA, TX, MN, ME, AZ, FL, VA, MI, NJ, NC, NY, CO, WI, MS, BRUSSELS, GREECE, SWEDEN, ENGLAND, SPAIN, CANADA & SWITZERLAND

    Quantity

    631 as individual vials, 1 bulk unit and 401 sold in kits