BEUDAMED
    FDA Enforcement Class II Terminated

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

    Recall: Z-1076-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1076-2019
    Event ID
    82116
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    July 18, 2018
    Classification Date
    March 30, 2019
    Termination Date
    August 13, 2020
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    Description

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

    Reason

    The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

    Code Info

    Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.

    Distribution

    Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Moldova, Morocco, Netherlands, Netherlands (Curacao), New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Vietnam, and Zimbabwe.

    Quantity

    30 kits