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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)
2016 2017 2018 2019 2020 2021
21 17 36 16 15 0

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 3 3
Insufficient Information 2 2
Break 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Therapeutic Response, Decreased 2 2
Foreign Body In Patient 1 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
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