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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
2017 5 5
2018 34 34
2019 16 16
2020 8 8
2021 10 10
2022 7 7
2023 4 4
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 51 51
Device Ingredient or Reagent Problem 25 25
Break 15 15
Leak/Splash 7 7
Device Contamination with Chemical or Other Material 6 6
Incorrect Or Inadequate Test Results 5 5
Volume Accuracy Problem 5 5
Short Fill 4 4
Fracture 2 2
Component Missing 1 1
Device Markings/Labelling Problem 1 1
Material Deformation 1 1
Device Operates Differently Than Expected 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
No Known Impact Or Consequence To Patient 48 48
No Consequences Or Impact To Patient 11 11
No Information 4 4
No Code Available 1 1
No Patient Involvement 1 1
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Aug-22-2014
2 Sigma-Aldrich Mfg LLC II Mar-04-2010
3 Sigma-Aldrich Mfg LLC II Mar-04-2010
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