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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
Product CodeJCF
Regulation Number 864.8500
Device Class 1

MDR Year MDR Reports MDR Events
2018 34 34
2019 16 16
2020 8 8
2021 10 10
2022 7 7
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 43 43
Break 10 10
Volume Accuracy Problem 5 5
Incorrect Or Inadequate Test Results 5 5
Device Contamination with Chemical or Other Material 5 5
Leak/Splash 5 5
Short Fill 4 4
Device Ingredient or Reagent Problem 3 3
Fracture 2 2
Component Missing 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 47 47
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 7 7
No Information 4 4
No Code Available 1 1
No Patient Involvement 1 1

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