BEUDAMED
    FDA Recall Terminated

    BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.

    Recall: Z-1561-2008 · Initiated September 6, 2007

    Recall

    Recall Number
    Z-1561-2008
    Event Number
    46750
    Firm
    BD Diagnostic Systems Lee Laboratories
    FEI Number
    1025402
    Product Code
    GTJ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 6, 2007
    Posted
    August 8, 2008
    Terminated
    March 24, 2009
    Address
    1475 Athens Hwy, Grayson, GA, 30017-1538

    Description

    BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.

    Reason

    Exhibits cross reactivity with Neisseria meningitides Group W135

    Action

    BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.

    Distribution

    Worldwide Distribution --- including USA and country of New Zealand.

    Quantity

    200 units