BEUDAMED
    FDA Enforcement Class II Terminated

    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

    Recall: Z-1843-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1843-2015
    Event ID
    71363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    May 6, 2015
    Classification Date
    June 25, 2015
    Termination Date
    June 22, 2016
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

    Reason

    IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

    Code Info

    Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

    Distribution

    Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.

    Quantity

    Domestic: 17 kits, Foreign: 1549 kits