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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
2017 5 5
2018 34 34
2019 16 16
2020 8 8
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 40 40
Break 10 10
Incorrect Or Inadequate Test Results 5 5
Leak/Splash 4 4
Volume Accuracy Problem 4 4
Short Fill 3 3
Device Contamination with Chemical or Other Material 2 2
Material Deformation 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48 48
No Consequences Or Impact To Patient 11 11
No Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Code Available 1 1
No Patient Involvement 1 1

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