BEUDAMED
    FDA Enforcement Class II Terminated

    PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

    Recall: Z-2425-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2425-2018
    Event ID
    79602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dako North America Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    February 2, 2018
    Classification Date
    July 11, 2018
    Termination Date
    November 10, 2020
    Address
    1170 Mark Ave, Carpinteria, CA, 93013-2918, United States

    Description

    PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

    Reason

    To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.

    Code Info

    Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199

    Distribution

    AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NH, NJ, NV, NY, OH, OK, PA, TX, UT, VA, WA, and WI

    Quantity

    1051 kits