BEUDAMED
    FDA Recall Terminated

    BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.

    Recall: Z-1149-2010 · Initiated January 25, 2010

    Recall

    Recall Number
    Z-1149-2010
    Event Number
    54374
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LIA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 25, 2010
    Posted
    March 16, 2010
    Terminated
    May 21, 2010
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.

    Reason

    In vitro diagnostic test reagent may exhibit decreased reactivity.

    Action

    BD Diagnostic Systems issued an "Urgent Product Recall" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit. For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908.

    Distribution

    Nationwide Distribution

    Quantity

    1096 units