Class 2 Device Recall PDL1 IHC 22C3 pharmDx

• Date Initiated by Firm: February 02, 2018
• Create Date: July 11, 2018
• Recall Status: Terminated on November 10, 2020
• Recall Number: Z-2425-2018
• Recall Event ID: 79602
• PMA Number: P150013S006
• Product Classification: Immunohistochemistry assay, antibody, programmed death-ligand 1 - Product Code PLS
• Product: PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
• Code Information: Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199
• Recalling Firm/ Manufacturer: Dako North America Inc.; 1170 Mark Ave; Carpinteria CA 93013-2918
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• 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
• Quantity in Commerce: 1051 kits
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = PLS and Original Applicant = Agilent Technologies, Inc.