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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer
Definition This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist.
Product CodeNYQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 5 7 11 7 5 5 5 1 2 4 2 6 4 2

MDR Year MDR Reports MDR Events
2014 7 7
2016 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 3 3
Device Operates Differently Than Expected 2 2
False Positive Result 2 2
Improper or Incorrect Procedure or Method 1 1
Incorrect Or Inadequate Test Results 1 1
Device Displays Incorrect Message 1 1
Chemical Problem 1 1
False Negative Result 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Information 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cell Marque Corporation II Jun-01-2017
2 Dako North America Inc. II Jun-29-2016
3 Dako North America Inc. II Feb-26-2014
4 Life Technologies Corporation II Aug-26-2013
5 Life Technologies Corporation II Jan-11-2012
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