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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)
2021 2022 2023 2024 2025 2026
2 4 18 17 14 3

MDR Year MDR Reports MDR Events
2021 9 9
2022 4 4
2023 34 34
2024 68 70
2025 96 96
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 165 167
False Positive Result 30 30
Device Markings/Labelling Problem 12 12
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Computer Operating System Problem 3 3
Missing Information 3 3
Contamination 2 2
No Device Output 2 2
Mechanical Problem 1 1
Output Problem 1 1
Unintended Movement 1 1
Unable to Obtain Readings 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 219 221
Insufficient Information 2 2
Aspiration/Inhalation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Oct-29-2024
2 Becton Dickinson & Co. II Jul-23-2025
3 Becton Dickinson & Co. II Dec-03-2024
4 GET TESTED INTERNATIONAL AB II Dec-01-2025
5 Roche Molecular Systems, Inc. II Jan-12-2021
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