BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 12, 2025

    Recall

    Recall Number
    Z-2336-2025
    Event Number
    97090
    Firm
    Immunotech A.S. Radiova 1 Prague
    FEI Number
    3003385757
    Product Code
    CGF
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 12, 2025
    Posted
    August 18, 2025
    Address
    10 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.

    Action

    On 06/12/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. Customers are instructed to: Beckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025) For questions, contact Customer Support Center: Website: http://www.beckmancoulter.com Email: [email protected]

    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