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U.S. Department of Health and Human Services

Class 2 Device Recall Dako HER2 CISH pharmDx Kit

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  Class 2 Device Recall Dako HER2 CISH pharmDx Kit see related information
Date Initiated by Firm June 10, 2016
Create Date June 29, 2016
Recall Status1 Terminated 3 on September 02, 2016
Recall Number Z-2099-2016
Recall Event ID 74408
Product Classification Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
Product 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.
Code Information 20031683
Recalling Firm/
Manufacturer		 Dako North America Inc.
1170 Mark Ave
Carpinteria CA 93013-2918
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 31 kits
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.
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.
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