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Terminated

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

FDA Recall Z-2425-2018 · Posted None

Recalling FirmDako North America Inc.
Recall StatusTerminated
Product CodePLS
Date Initiated2018-02-02
Date Terminated2020-11-10
Product Quantity1051 kits

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.

Firm 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

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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