BEUDAMED
    FDA Recall Terminated

    Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001

    Recall: Z-0774-06 · Initiated April 4, 2006

    Recall

    Recall Number
    Z-0774-06
    Event Number
    34904
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2006
    Posted
    April 19, 2006
    Terminated
    July 3, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001

    Reason

    The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

    Action

    Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.

    Distribution

    Nationwide.

    Quantity

    251