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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
2021 30 30
2022 44 44
2023 36 36
2024 15 15
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 49 49
Contamination 39 39
Fluid/Blood Leak 33 33
Device Fell 4 4
Leak/Splash 3 3
Smoking 3 3
False Positive Result 2 2
False Negative Result 1 1
Fire 1 1
Non Reproducible Results 1 1
Unintended Movement 1 1
Obstruction of Flow 1 1
Device Handling Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Environmental Particulates 1 1
Melted 1 1
Unintended System Motion 1 1
Improper or Incorrect Procedure or Method 1 1
Misfocusing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 134
No Patient Involvement 3 3
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
No Consequences Or Impact To Patient 1 1
Cancer 1 1

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