BEUDAMED
    FDA Enforcement Class II Terminated

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    Recall: Z-1316-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1316-2014
    Event ID
    67586
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    February 3, 2014
    Classification Date
    April 2, 2014
    Termination Date
    June 30, 2016
    Address
    62 Flanders-Bartley Rd, N/A, Flanders, NJ, 07836-4715, United States

    Description

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    Reason

    There is a potential for incorrect results to be reported from processing of a sample tube.

    Code Info

    IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

    Distribution

    Nationwide and Foreign Distribution.

    Quantity

    1006 units