BEUDAMED
    FDA Enforcement Class II Terminated

    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

    Recall: Z-1321-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1321-2013
    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 (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

    Reason

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

    Code Info

    Catalog Number 4503223, Lot #142345647, 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