BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

    Recall: Z-0994-05 · Initiated April 22, 2005

    Recall

    Recall Number
    Z-0994-05
    Event Number
    32010
    Firm
    DPC Cirrus
    FEI Number
    1000122204
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 22, 2005
    Posted
    July 16, 2005
    Terminated
    June 29, 2006
    Address
    62 Flanders Bartley Rd, Flanders, NJ, 07836-4715

    Description

    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

    Reason

    The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.

    Action

    The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.

    Distribution

    worldwide

    Quantity

    There are 941 units in the United States and 3014 units in the international market.