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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, dna detection, human papillomavirus
Product CodeMAQ
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
6 8 28 11 14 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2018 2 2
2020 1 1
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Incorrect Or Inadequate Test Results 3 3
False Negative Result 3 3
False Positive Result 2 2
Contamination 2 2
Crack 1 1
Contamination of Device Ingredient or Reagent 1 1
Output Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 6 6
Cancer 1 1
Insufficient Information 1 1
Misdiagnosis 1 1
Anxiety 1 1
Distress 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jan-12-2021
2 Ventana Medical Systems Inc I Sep-14-2018
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