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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device next generation sequencing oncology panel, somatic or germline variant detection system
Definition A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Product CodePQP
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 1 6 15 21 24 17 33 34 5

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2020 1 1
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2
False Positive Result 1 1
Inadequate Instructions for Healthcare Professional 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unexpected Therapeutic Results 1 1
Incorrect Or Inadequate Test Results 1 1
Ambient Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGILENT TECHNOLOGIES INC./US III Apr-11-2023
2 Foundation Medicine, Inc. II Nov-22-2019
3 Foundation Medicine, Inc. II Dec-20-2018
4 Life Technologies Corporation II Apr-14-2020
5 Life Technologies Corporation II Apr-20-2018
6 Life Technologies Corporation II Mar-30-2018
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