BEUDAMED
    FDA Recall 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 · Initiated February 2, 2018

    Recall

    Recall Number
    Z-2425-2018
    Event Number
    79602
    Firm
    Dako North America Inc.
    FEI Number
    2022180
    Product Code
    PLS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 2, 2018
    Terminated
    November 10, 2020
    Address
    1170 Mark Ave, Carpinteria, CA, 93013-2918

    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.

    Action

    On February 2, 2018 the firm sent letters to the consignees with the following instructions; Description of the issue: The Field Correction has been initiated to correct the kit's Instructions for Use (I FU) as the storage time for Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma cut sections will be changed from six months to five months. This means that section 8.2: Cut Section Storage Recommendation will be changed to the following: 'To preserve antigenicity, tissue sections, once mounted on slides, should be held in the dark at 2-8 C (preferred), or at room temperature up to 25 C. Slide storage and handling conditions should not exceed 25 C at any point post-mounting to ensure tissue integrity and antigenicity. 8.2.1 NSCLC Cut Section Storage Recommendation Cut sections must be stained within 6 months when stored at 2-8 C (preferred), or at 25 C. 8.2.2 Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Cut Section Storage Recommendation Cut sections must be stained within 5 months when stored at 2-8 C (preferred), or at 25 C." Note that only Gastric and Gastroesophageal Junction (GEJl Adenocarcinoma cut section storage time has been updated. Storage time for Non-Small Cell Lung Cancer (NSCLCl cut sections remains the ~ You may continue the use of PD-Ll IHC 22C3 pharmDx, Code No. SK006. However, we recommend that your laboratory follow the instructions noted to preseive the antigenicity, as this may decrease after five months of cut section storage. Potential patient risk: Based on our investigations, there is a remote possibility that staining Gastric and Gastroesophageal (GEJ) Adenocarcinoma cut sections may result in a weak staining or a false negative staining after five months of storage. However, there have been no reported incidents based on the previous storage time recommendation. Actions to be taken by the user: Within 10 calendar days, please take the following actions 1. Discard the IFU provided within the PD-Ll

    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