BEUDAMED
    FDA Enforcement Class II Terminated

    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age

    Recall: Z-0082-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0082-2017
    Event ID
    75037
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    August 24, 2016
    Classification Date
    October 13, 2016
    Termination Date
    May 24, 2018
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age

    Reason

    Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.

    Code Info

    Kit lots 236M, 237, 238, 239, 239L (OUS) and D236M and D238 (US)

    Distribution

    Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.

    Quantity

    Domestic: 177 Kits; Foreign: 3435 Kits