BEUDAMED
    FDA Enforcement Class II Terminated

    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    Recall: Z-2874-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2874-2018
    Event ID
    80491
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    January 23, 2018
    Classification Date
    August 17, 2018
    Termination Date
    July 13, 2021
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320, United States

    Description

    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    Reason

    Missing desiccant.

    Code Info

    Batch/Lot: 245057043 Exp. Date 19JUN2019

    Distribution

    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV

    Quantity

    57 cartons