BEUDAMED
    FDA Enforcement Class II Ongoing

    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

    Recall: Z-0234-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0234-2025
    Event ID
    95442
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 12, 2024
    Classification Date
    October 28, 2024
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

    Reason

    Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

    Code Info

    a) REF 09N17-095, UDI/DI 00884999048591; b) REF 09N17-090, UDI/DI 00884999047945; c) REF 09N17-091, UDI/DI 00884999049277 All Lots

    Distribution

    Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.

    Quantity

    15068 units