BEUDAMED
    FDA Enforcement Class II Ongoing

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    Recall: Z-2007-2021 · Reported July 14, 2021

    Enforcement

    Recall Number
    Z-2007-2021
    Event ID
    88137
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 14, 2021
    Initiation Date
    October 30, 2020
    Classification Date
    July 2, 2021
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829, United States

    Description

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    Reason

    Potential for a false-negative result.

    Code Info

    030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A

    Distribution

    Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

    Quantity

    36,416