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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 January 21, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-1093-2014
Recall Event ID 67380
PMA Number P100024 
Product Classification Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
Product Product Name: HER2 CISH pharmDx Kit
Catalog/Model number: SK109, lot 20000910

Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color 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 Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.  
Recalling Firm/
Manufacturer		 Dako North America Inc.
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information Contact
805-566-6655
Manufacturer Reason
for Recall		 Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
FDA Determined
Cause 2		 Device Design
Action Dako sent a Recall Notification letter dated January 21, 2014to affected customers via mail. The letter identified the affected product, description of the problem, actions to be taken by the user, communication, and Dako contact information. The letter was accompanied by a "Recall Form (Product Recall Form to customers)". For questions call 805-566-5464.
Quantity in Commerce 49
Distribution Worldwide Distribution - USA Nationwide and in the country of Chile.
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 = NYQ and Original Applicant = DAKO DENMARK A/S
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