BEUDAMED
    FDA Recall Open, Classified

    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

    Recall: Z-0233-2025 · Initiated September 12, 2024

    Recall

    Recall Number
    Z-0233-2025
    Event Number
    95442
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MAQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 12, 2024
    Posted
    October 29, 2024
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

    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.

    Action

    Abbott issued an "Urgent Field Safety Notice" dated 9/11/2024 to its consignees on 09/12/2024 via FedEx priority overnight express. The notice explained the issue, potential impact, and provided the following information: "Necessary Actions " If you experience an increased incidence of Error Code 9198 (Positive control is non-reactive) while testing the Alinity m HR HPVor Alinity m STI assay, please contact Abbott Technical Support at 1-800-553-7042 Option 2 for additional troubleshooting information. " Complete and return the associated Customer Reply Form. If you have forwarded this product to any other laboratories, please also forward this letter and customer reply form to that laboratory. Review this information with laboratory personnel and retain this communication for future reference." If you have any questions regarding this communication, please contact your local Abbott representative or call: 1-224-361-7000.

    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

    13318 units