Events

Recall of Device Recall Dako HER2 CISH pharmDx Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dako North America Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74408
  • Event Risk Class
    Class 2
  • Event Number
    Z-2099-2016
  • Event Initiated Date
    2016-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147442
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
  • Reason
    An incorrect her2 probe concentration was used when producing the probe component (vial 3) in this kit lot. this has resulted in the her2 probe concentration being too low.
  • Action
    Dako sent a recall notification dated June 10, 2016 to all customers. The letter identified the affected product, problem, the investigation findings, the affected results, and the actions to be taken. Customers are instructed to complete and return the enclosed device recall form to Dako QA Vigilance by Dako.dkvigilance@agilent.com. Customers with questions regarding the notification, are instructed to contact their sales representative.

Device

Device Recall Dako HER2 CISH pharmDx Kit
  • Model / Serial
    20031683
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
  • Product Description
    Dako HER2 CISH pharmDx Kit, product code: SK 109 || Product Usage: || For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Manufacturer Address
    Dako North America Inc., 1170 Mark Ave, Carpinteria CA 93013-2918
  • Source
    USFDA