BEUDAMED
    FDA Recall Terminated

    STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.

    Recall: Z-0501-2009 · Initiated October 20, 2008

    Recall

    Recall Number
    Z-0501-2009
    Event Number
    50125
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 20, 2008
    Posted
    December 18, 2008
    Terminated
    June 24, 2010
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.

    Reason

    Internal investigation has determined the potential lack of homogeneity between product vials.

    Action

    Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached "Product Recall Response Form" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.

    Distribution

    Nationwide Distribution.

    Quantity

    1,280 units