BEUDAMED
    FDA Recall Terminated

    VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    Recall: Z-1873-2008 · Initiated May 28, 2008

    Recall

    Recall Number
    Z-1873-2008
    Event Number
    48464
    Firm
    Sun Biomedical Laboratories, Inc.
    FEI Number
    1000526795
    Product Code
    DJR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 28, 2008
    Posted
    September 17, 2008
    Terminated
    June 10, 2009
    Address
    1001 Lower Landing Rd, Blackwood, NJ, 08012-3124

    Description

    VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    Reason

    Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

    Action

    On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.

    Quantity

    330 kits of product VIX-OXD-Dip 07-081-1-257; 1 kits of Vix-OXD-07-018-275