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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device station, pipetting and diluting, for clinical use
Regulation Description Pipetting and diluting system for clinical use.
Product CodeJQW
Regulation Number 862.2750
Device Class 1

MDR Year MDR Reports MDR Events
2020 27 27
2021 30 30
2022 44 44
2023 36 36
2024 15 15
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Fluid/Blood Leak 47 47
Contamination 36 36
Device Fell 4 4
Smoking 3 3
Leak/Splash 3 3
False Positive Result 2 2
Non Reproducible Results 1 1
Unintended Movement 1 1
Melted 1 1
Fire 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Obstruction of Flow 1 1
False Negative Result 1 1
Environmental Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 134
No Consequences Or Impact To Patient 17 17
No Patient Involvement 12 12
Unspecified Tissue Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Needle Stick/Puncture 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Co II Feb-27-2021
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