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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device kit, dna detection, human papillomavirus
Product CodeMAQ
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
11 14 2 4 18 10

MDR Year MDR Reports MDR Events
2020 1 1
2021 9 9
2022 4 4
2023 35 35
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 51 51
Device Markings/Labelling Problem 12 12
False Positive Result 10 10
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Missing Information 3 3
Contamination 2 2
Output Problem 1 1
Unintended Movement 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
Insufficient Information 2 2
Misdiagnosis 1 1
Anxiety 1 1
Distress 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jan-12-2021
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