BEUDAMED
    FDA Enforcement Class II Ongoing

    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

    Recall: Z-2336-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2336-2025
    Event ID
    97090
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Immunotech A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2025
    Initiation Date
    June 12, 2025
    Classification Date
    August 18, 2025
    Address
    Radiova 1, N/A, Prague 10, N/A, N/A, Czech Republic

    Description

    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

    Reason

    Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

    Code Info

    Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.

    Quantity

    279 units