BEUDAMED
    FDA Recall Terminated

    Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi.

    Recall: Z-1255-2009 · Initiated February 9, 2009

    Recall

    Recall Number
    Z-1255-2009
    Event Number
    51071
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LXG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 9, 2009
    Posted
    May 18, 2009
    Terminated
    December 7, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi.

    Reason

    Protruding screw threads may cut the user when cleaning the interior of the instrument.

    Action

    In a letter titled "Urgent Medical Device Correction" dated February 9, 2009, consignees were notified of the protruding screws and instructed to use caution when cleaning the instrument until a protective plate is installed by the firm's field representative. Further questions should be addressed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.

    Distribution

    Nationwide Distribution including Puerto Rico and states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV.

    Quantity

    371