BEUDAMED
    FDA Enforcement Class II Terminated

    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

    Recall: Z-2401-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2401-2020
    Event ID
    85686
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Gmbh & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    June 18, 2020
    Termination Date
    January 31, 2023
    Address
    Max-Planck-Ring 2, 65205, Wiesbaden, N/A, Germany

    Description

    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

    Reason

    There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

    Code Info

    List Number: 03R67-01: All serial numbers

    Distribution

    U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.

    Quantity

    421 serial numbers