BEUDAMED
    FDA Recall Terminated

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    Recall: Z-2088-2019 · Initiated June 5, 2019

    Recall

    Recall Number
    Z-2088-2019
    Event Number
    83199
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 5, 2019
    Posted
    August 1, 2019
    Terminated
    August 28, 2020
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    Reason

    Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

    Action

    QIAGEN issued Urgent Device Notification dated June 5, 2019 stating problem, health risk and action to take: Forward this information to all individuals and departments who are using the above listed kit within your organization. If you are not the end user, please forward this notice to the product end user. If you have any remaining stocks of Filter-Tips, 1500 l (1024) REF 997024, lots 0605020019 and 0605020020, DO NOT USE them. For a free-of-charge replacement, please contact QIAGEN Technical Service. Dispose of the product in accordance with your national and local safety and environmental regulations. l Review this notice with your laboratory/medical director. l If you have used the affected kits with lots 0605020019 and/or 0605020020, we recommend a review of the corresponding results. l Complete the Acknowledgement of Receipt form attached to this letter by June 12, 2019 and email it to [email protected]. Questions or concerns, contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: [email protected]

    Distribution

    US Nationwide distribution

    Quantity

    1240 Kits