BEUDAMED
    FDA Enforcement Class II Terminated

    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

    Recall: Z-0131-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0131-2015
    Event ID
    67987
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    April 7, 2014
    Classification Date
    October 27, 2014
    Termination Date
    April 1, 2015
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    Description

    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

    Reason

    Package inserts have incorrect SmartWash parameters for Triglyceride.

    Code Info

    lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.

    Quantity

    11916 units