BEUDAMED
    FDA Recall Terminated

    STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.

    Recall: Z-0853-2007 · Initiated March 13, 2007

    Recall

    Recall Number
    Z-0853-2007
    Event Number
    37746
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 13, 2007
    Posted
    July 3, 2007
    Terminated
    January 16, 2009
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.

    Reason

    A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.

    Action

    Customers were notified on March 13, 2007 by letter, first class mail.

    Distribution

    Hospitals and laboratories Nationwide

    Quantity

    1,098 units