BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity ci-series System Control Module, REF: 03R70-01

    Recall: Z-0613-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0613-2024
    Event ID
    93483
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2024
    Initiation Date
    May 30, 2023
    Classification Date
    December 22, 2023
    Address
    1915 Hurd Dr, Irving, TX, 75038-4313, United States

    Description

    Alinity ci-series System Control Module, REF: 03R70-01

    Reason

    There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

    Code Info

    UDI-DI: 00380740137410. Software Version 3.4.0 and lower.

    Distribution

    US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, , GAZA & JERICHO,GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LITHUANIA, MACEDONIA, MADAGASCAR, MALAYSIA, MALDIVES, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, VIETNAM, ZAMBIA

    Quantity

    8,424