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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lymphocyte separation medium
Regulation Description Lymphocyte separation medium.
Product CodeJCF
Regulation Number 864.8500
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 10 10
2022 7 7
2023 4 4
2024 54 54
2025 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Device Ingredient or Reagent Problem 35 35
Break 14 14
Device Contamination with Chemical or Other Material 10 10
Short Fill 6 6
Leak/Splash 4 4
Volume Accuracy Problem 4 4
Clumping in Device or Device Ingredient 4 4
Coagulation in Device or Device Ingredient 4 4
Fracture 2 2
Component Missing 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 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 1 1
Exposure to Body Fluids 1 1

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