BEUDAMED
    FDA Recall Terminated

    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test

    Recall: Z-1528-2008 · Initiated November 30, 2007

    Recall

    Recall Number
    Z-1528-2008
    Event Number
    46323
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    GNB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 30, 2007
    Posted
    August 16, 2008
    Terminated
    November 12, 2008
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test

    Reason

    In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

    Action

    The recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.

    Distribution

    Worldwide Distribution

    Quantity

    643 (recall total) vials