BEUDAMED
    FDA Recall Terminated

    BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.

    Recall: Z-0268-05 · Initiated October 29, 2004

    Recall

    Recall Number
    Z-0268-05
    Event Number
    30445
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2004
    Posted
    November 30, 2004
    Terminated
    January 31, 2005
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.

    Reason

    The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.

    Action

    BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.

    Distribution

    Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.