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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
2019 16 16
2020 8 8
2021 10 10
2022 7 7
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Break 8 8
Short Fill 4 4
Volume Accuracy Problem 4 4
Leak/Splash 3 3
Device Ingredient or Reagent Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Fracture 2 2
Coagulation in Device or Device Ingredient 1 1
Component Missing 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 6 6
No Patient Involvement 1 1
No Information 1 1
No Code Available 1 1

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