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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
Product CodeJQW
Regulation Number 862.2750
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 27 27
2021 30 30
2022 44 44
2023 36 36
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 47 47
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Contamination 36 36
Device Fell 4 4
Leak/Splash 3 3
Smoking 3 3
False Positive Result 2 2
Fire 1 1
False Negative Result 1 1
Obstruction of Flow 1 1
Contamination of Device Ingredient or Reagent 1 1
Environmental Particulates 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Melted 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 17 17
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 3 3
Cancer 1 1
Unspecified Tissue Injury 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Co II Feb-27-2021
2 Tecan US, Inc. II Jun-21-2019
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