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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 somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Product CodeOWD
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
6 31 21 17 36 15

Device Problems
Incorrect Or Inadequate Test Results 1
Total Device Problems 1

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

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