BEUDAMED
    FDA Recall Terminated

    BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***

    Recall: Z-0366-2011 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-0366-2011
    Event Number
    57001
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 14, 2010
    Posted
    November 15, 2010
    Terminated
    November 29, 2010
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***

    Reason

    The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.

    Action

    BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.

    Distribution

    Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.

    Quantity

    1675 units