BEUDAMED
    FDA Recall Terminated

    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

    Recall: Z-1138-03 · Initiated June 13, 2003

    Recall

    Recall Number
    Z-1138-03
    Event Number
    26892
    Firm
    DPC Cirrus
    FEI Number
    1000122204
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 13, 2003
    Posted
    August 20, 2003
    Terminated
    November 1, 2004
    Address
    62 Flanders-Bartley Road, Flanders, NJ, 07836

    Description

    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

    Reason

    Version 2.6 software was released however it will not properly handle adjustment slopes.

    Action

    Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.

    Distribution

    Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.

    Quantity

    434 upgrades