BEUDAMED
    FDA Enforcement Class II Terminated

    Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

    Recall: Z-2330-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2330-2019
    Event ID
    83406
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    July 17, 2019
    Classification Date
    August 22, 2019
    Termination Date
    May 13, 2020
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

    Reason

    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

    Code Info

    Lot # 9085672; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085672(30)1; Exp:10/11/2020 Lot # 9085673; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085673(30)1; Exp:10/11/2020 Lot # 9106961; UDI (GTIN, DI+PI): (01)00382904429638 (17)201011(10)9106961(30)1; Exp:10/11/2020 Lot # 9106962; UDI (GTIN, DI+PI): (01)00382904429638 (17)201102(10)9106962(30)1; Exp:11/2/2020

    Distribution

    AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

    Quantity

    994 units