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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)
2019 2020 2021 2022 2023 2024
1 1 4 0 1 0

MDR Year MDR Reports MDR Events
2020 1 1
2021 24 24
2022 17 17
2023 77 77
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 38 38
Contamination 28 28
Structural Problem 14 14
Break 14 14
Device Markings/Labelling Problem 9 9
False Negative Result 9 9
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Crack 5 5
Microbial Contamination of Device 3 3
Fire 1 1
Fluid/Blood Leak 1 1
Grounding Malfunction 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Patient Data Problem 1 1
Non Reproducible Results 1 1
Inaccurate Information 1 1
Missing Information 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 127 127
No Consequences Or Impact To Patient 1 1
Foreign Body In Patient 1 1

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