BEUDAMED
    FDA Enforcement Class II Terminated

    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798

    Recall: Z-2105-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2105-2021
    Event ID
    88072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cell Marque Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 28, 2021
    Initiation Date
    May 27, 2021
    Classification Date
    July 21, 2021
    Termination Date
    April 5, 2024
    Address
    6600 Sierra College Blvd, N/A, Rocklin, CA, 95677-4306, United States

    Description

    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798

    Reason

    Product distributed for use as an In-vitro Diagnostics without FDA clearance

    Code Info

    Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023

    Distribution

    US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

    Quantity

    41 kits