BEUDAMED
    FDA Enforcement Class II Terminated

    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

    Recall: Z-1320-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1320-2013
    Event ID
    64650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    QIAGEN Gaithersburg, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2013
    Initiation Date
    January 30, 2013
    Classification Date
    May 14, 2013
    Termination Date
    July 1, 2013
    Address
    1201 Clopper Rd, Gaithersburg, MD, 20878-4000, United States

    Description

    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

    Reason

    CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

    Code Info

    Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14

    Distribution

    USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.

    Quantity

    90 kits in total