BEUDAMED
    FDA Recall Terminated

    Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

    Recall: Z-1373-06 · Initiated July 17, 2006

    Recall

    Recall Number
    Z-1373-06
    Event Number
    35790
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NPQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 17, 2006
    Posted
    August 5, 2006
    Terminated
    December 4, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

    Reason

    If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.

    Action

    Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.

    Distribution

    Nationwide.

    Quantity

    771 total for recalls Z-1372-1374-06