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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device processor, cervical cytology slide, automated
Definition It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Product CodeMKQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 0 1 1 1 0

MDR Year MDR Reports MDR Events
2021 24 24
2022 17 17
2023 77 77
2024 56 56
2025 38 38
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 71 71
Contamination 45 45
Device Markings/Labelling Problem 28 28
Structural Problem 21 21
Break 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
False Negative Result 11 11
Computer Operating System Problem 9 9
Crack 5 5
Microbial Contamination of Device 3 3
Fire 1 1
Contamination of Device Ingredient or Reagent 1 1
Non Reproducible Results 1 1
Grounding Malfunction 1 1
Missing Information 1 1
Inaccurate Information 1 1
Difficult to Open or Close 1 1
Fluid/Blood Leak 1 1
Excessive Heating 1 1
Patient Data Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 222 222
No Consequences Or Impact To Patient 1 1

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