BEUDAMED
    FDA Enforcement Class I 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 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2088-2019
    Event ID
    83199
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2019
    Initiation Date
    June 5, 2019
    Classification Date
    August 1, 2019
    Termination Date
    August 28, 2020
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    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)

    Code Info

    Lot Numbers: 0605020019 and 0605020020

    Distribution

    US Nationwide distribution

    Quantity

    1240 Kits