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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device somatic gene mutation detection system
Definition The FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and the tyrosine kinase domain (TKD) mutations D835 and I836 in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia. The FLT3 Mutation Assay is used as an aid in the assessment of acute myeloid leukemia patients for whom midostaurin treatment is being considered. The FLT3 Mutation Assay is to be performed only at a preapproved laboratory site.
Product CodeOWD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 3 4 10 6 31 21 2

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 1

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 0 0 0 0 2 0
Class III 0 0 0 0 0 1 0 0 2 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jul-21-2016
2 Roche Molecular Systems, Inc. II May-26-2016
3 Roche Molecular Systems, Inc. III Jun-26-2015
4 Roche Molecular Systems, Inc. III Mar-25-2015
5 Roche Molecular Systems, Inc. III Nov-02-2012

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