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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)
2020 2021 2022 2023 2024 2025
14 2 4 18 17 0

MDR Year MDR Reports MDR Events
2020 1 1
2021 9 9
2022 4 4
2023 35 35
2024 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 78 78
Device Markings/Labelling Problem 12 12
False Positive Result 12 12
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Missing Information 3 3
Contamination 2 2
Output Problem 1 1
Unintended Movement 1 1
Use of Device Problem 1 1
Device Emits Odor 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 113 113
Insufficient Information 2 2
Misdiagnosis 1 1
Aspiration/Inhalation 1 1
No Known Impact Or Consequence To Patient 1 1
Anxiety 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Oct-29-2024
2 Becton Dickinson & Co. II Dec-03-2024
3 Roche Molecular Systems, Inc. II Jan-12-2021
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