BEUDAMED
    FDA Recall Terminated

    MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.

    Recall: Z-0956-2007 · Initiated May 14, 2007

    Recall

    Recall Number
    Z-0956-2007
    Event Number
    37948
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 14, 2007
    Posted
    June 22, 2007
    Terminated
    December 17, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.

    Reason

    False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.

    Action

    Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks.

    Distribution

    Nationwide.

    Quantity

    4,201