BEUDAMED
    FDA Enforcement Class II Terminated

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    Recall: Z-2596-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2596-2018
    Event ID
    80430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    QIAGEN
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    May 28, 2018
    Classification Date
    August 2, 2018
    Termination Date
    April 5, 2019
    Address
    19300 GERMANTOWN RD, GERMANTOWN MD 20874 USA, KOELN, N/A, N/A, Germany

    Description

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    Reason

    Underfilled reagent well that could lead to incorrect results

    Code Info

    UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19

    Distribution

    Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA

    Quantity

    287 pcs