BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000 Total Testosterone Kit

    Recall: Z-0528-06 · Initiated January 3, 2006

    Recall

    Recall Number
    Z-0528-06
    Event Number
    34480
    Firm
    Diagnostic Products Corp.
    FEI Number
    3005250747
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 3, 2006
    Posted
    February 16, 2006
    Terminated
    August 30, 2006
    Address
    5210 Pacific Concourse Dr, Los Angeles, CA, 90045-6900

    Description

    IMMULITE 2000 Total Testosterone Kit

    Reason

    The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.

    Action

    For domestic customers - the recall is extended to the domestic end user-level. Domestic customers were notified via telephone using a Phone Script (attached in Attachment 5), starting on January 5,2005. Each customer receives a fax-back form and a Technical Bulletin directly after this phone contact. For foreign consignees - the recall is extended to foreign distributors. It is the distributor''s responsibility to extend the recall action to their direct customers. Foreign consignees were notified via e-mail and/or FAX,starting on January 3, 2005.

    Distribution

    Nationwide and Worldwide in Pakistan, Italy, Cyprus, Turkey, Switzerland, Chile, South Africa, Greece, Mexica, Canada, Thialand, Germany, India, United Arab Emirates, Hungary, Israel, Portugal, Taiwan, Austria, Saudi Arabia, Malaysia, Hong Kong, India, Colombia, Argentina, Australia, Costa Rica, Czech Republic, Spain, France, Panama, Brazil, Netherlands, Poland, Sweden, United Kingdom, & El Salvadon.

    Quantity

    710