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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 71 71
Contamination 44 44
Device Markings/Labelling Problem 28 28
Structural Problem 21 21
Break 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
False Negative Result 11 11
Crack 5 5
Computer Operating System Problem 5 5
Microbial Contamination of Device 3 3
Fire 1 1
Non Reproducible Results 1 1
Unintended Movement 1 1
Patient Data Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Missing Information 1 1
Excessive Heating 1 1
Grounding Malfunction 1 1
Inaccurate Information 1 1
Difficult to Open or Close 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 217 217
No Consequences Or Impact To Patient 1 1

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