BEUDAMED
    FDA Enforcement Class II Ongoing

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    Recall: Z-0836-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0836-2025
    Event ID
    96022
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biocartis Nv
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    December 10, 2024
    Classification Date
    January 10, 2025
    Address
    B 3, Generaal De Wittelaan 11, Mechelen, N/A, Belgium

    Description

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    Reason

    False-positive MSI-H results generated by the Idylla MSI Test.

    Code Info

    UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.

    Distribution

    US: AL, NJ, TX, OH, CA

    Quantity

    8 units