BEUDAMED
    FDA Recall Open, Classified

    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

    Recall: Z-2152-2025 · Initiated June 12, 2025

    Recall

    Recall Number
    Z-2152-2025
    Event Number
    97132
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CGF
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 12, 2025
    Posted
    July 21, 2025
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

    Reason

    A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.

    Action

    On June 12, 2025, Beckman Coulter issued a "Urgent: Medical Device Recall" notification via Email. On July 8, 2025, Beckman Coulter issued a updated notification to provide additional information on the health risk and actions consignees should take. Beckman Coulter ask consignees to take the following actions: 1. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Please discard any remaining inventory of effective lots per your laboratory protocols and ask for replacement. 2. Please share this information with your laboratory staff and retain this notifications as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. Please respond within 10 days in one of the following ways: 1. Electronically, if you received the notification via email, 2. Manually, complete and return the enclosed Response Form.

    Distribution

    US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

    Quantity

    496 units