BEUDAMED
    FDA Recall Open, Classified

    Estrone RIA, REF: DSL8700

    Recall: Z-1369-2026 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1369-2026
    Event Number
    98219
    Firm
    Immunotech A.S. Radiova 1 Prague
    FEI Number
    3003385757
    Product Code
    CGF
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    December 15, 2025
    Posted
    February 13, 2026
    Address
    10 Czech Republic

    Description

    Estrone RIA, REF: DSL8700

    Reason

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

    Action

    On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to [email protected] Questions can be sent to the firm via email at [email protected]

    Distribution

    Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

    Quantity

    160