BEUDAMED
    FDA Recall Terminated

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

    Recall: Z-1075-2019 · Initiated July 18, 2018

    Recall

    Recall Number
    Z-1075-2019
    Event Number
    82116
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    CGS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    July 18, 2018
    Terminated
    August 13, 2020
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

    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.

    Action

    Recall letters were issued via FedEx overnight priority mail on 7/18/2018.

    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

    6,187 kits kits