BEUDAMED
    FDA Enforcement Class II Terminated

    Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

    Recall: Z-2126-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2126-2017
    Event ID
    77150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    January 1, 2017
    Classification Date
    May 22, 2017
    Termination Date
    February 24, 2022
    Address
    Chemin De L'Orme, Marcy L'Etoile, N/A, France

    Description

    Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

    Reason

    Potential performance issue on strain categorization.

    Code Info

    Ref 412302  1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058  1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030

    Distribution

    USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA

    Quantity

    4656 kits