BEUDAMED
    FDA Recall Open, Classified

    PhenoMATRIX

    Recall: Z-1812-2025 · Initiated May 6, 2025

    Recall

    Recall Number
    Z-1812-2025
    Event Number
    96765
    Firm
    Copan WASP Via Achille Grandi
    FEI Number
    3009288740
    Product Code
    KZB
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 6, 2025
    Posted
    May 21, 2025
    Address
    32 Brescia 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.

    Action

    On 5/6/2025, recall notices were mailed to customers informing them of the following: Ensure the plate images are reviewed against the actual agar plate to verify the assessment you performed by the digital image inspection. Complete and return the response form via email to [email protected]

    Distribution

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

    Quantity

    14