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
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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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PMA Database |
PMAs with Product Code = NYQ and Original Applicant = DAKO DENMARK A/S
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