BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1993-2025
    Event ID
    96937
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 25, 2025
    Initiation Date
    May 21, 2025
    Classification Date
    June 18, 2025
    Address
    5 Century Dr, N/A, Parsippany, NJ, 07054-4607, United States

    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%

    Code Info

    UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.

    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)