BEUDAMED
    FDA Recall Open, Classified

    STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

    Recall: Z-1993-2025 · Initiated May 21, 2025

    Recall

    Recall Number
    Z-1993-2025
    Event Number
    96937
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    PPM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 21, 2025
    Posted
    June 18, 2025
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

    Reason

    Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

    Action

    Diagnostica Stago, Inc. notified consignees on 05/21/2025 via email. Consignees were instructed to review inventory for any affected units, stop using the affected lot and destroy it, and complete and return the acknowledgement form.

    Distribution

    The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.

    Quantity

    939 US ( 2,810 total worldwide)