BEUDAMED
    FDA Enforcement Class II Ongoing

    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

    Recall: Z-0677-2025 · Reported December 18, 2024

    Enforcement

    Recall Number
    Z-0677-2025
    Event ID
    95829
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diasorin Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 18, 2024
    Initiation Date
    November 7, 2024
    Classification Date
    December 12, 2024
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536, United States

    Description

    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

    Reason

    Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.

    Code Info

    UDI/DI 80567713190605F, Lot Numbers: 225084, 232094, 234114, 259144, 221214, 252244, 230094, 224124, 205144, 228174, 228224, 223274, 219104, 217134, 233154, 236174, 224244, 232294, 229224, 251234, 221294, 210204, 223244, 222314

    Distribution

    Worldwide

    Quantity

    21905 units