BEUDAMED
    FDA Recall Terminated

    K 520411-2, Hercep Test, 35Test, HER2, Protein

    Recall: Z-0113-06 · Initiated September 29, 2005

    Recall

    Recall Number
    Z-0113-06
    Event Number
    33707
    Firm
    Dakocytomation California Inc
    FEI Number
    2022180
    Product Code
    MVC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2005
    Posted
    November 1, 2005
    Terminated
    January 29, 2007
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921

    Description

    K 520411-2, Hercep Test, 35Test, HER2, Protein

    Reason

    Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.

    Action

    Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.

    Distribution

    Nationwide

    Quantity

    545