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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 hybridisation, 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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 1 0 0 5 7 11 7 5 5 4

Device Problems
False positive result 1
Chemical issue 1
Device ingredient or reagent issue 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 1 1 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

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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