BEUDAMED
    FDA Enforcement Class II Ongoing

    PhenoMATRIX

    Recall: Z-1812-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1812-2025
    Event ID
    96765
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Copan WASP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    May 6, 2025
    Classification Date
    May 21, 2025
    Address
    Via Achille Grandi, 32, N/A, Brescia, N/A, N/A, Italy

    Description

    PhenoMATRIX

    Reason

    AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

    Code Info

    All software versions

    Distribution

    US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.

    Quantity

    14