BEUDAMED
    FDA Recall Terminated

    Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001.

    Recall: Z-0775-06 · Initiated April 4, 2006

    Recall

    Recall Number
    Z-0775-06
    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 DNA Isolation Kit - Large Volume; Catalog number 03310515001.

    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

    unknown.