BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

    Recall: Z-0489-2026 · Initiated September 18, 2025

    Recall

    Recall Number
    Z-0489-2026
    Event Number
    97788
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 18, 2025
    Posted
    November 12, 2025
    Address
    4551 Great America Pkwy, Santa Clara, CA, 95054-1208

    Description

    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

    Reason

    Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

    Action

    On September 18, 2025, Abbott Laboratories issued an "Urgent Medical Device Recall" Notification. Abbott ask consignees to take the following actions: 1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results. 2. Complete and return the Customer Reply Form. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4. Please retain this letter for your laboratory records. If the problem persists, contact your Abbott representative or Abbott Technical Support (1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.

    Distribution

    Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM, URUGUAY, and VIETNAM.

    Quantity

    833