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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 44 44
Break 14 14
Incorrect Or Inadequate Test Results 5 5
Volume Accuracy Problem 5 5
Leak/Splash 5 5
Device Contamination with Chemical or Other Material 5 5
Short Fill 4 4
Device Ingredient or Reagent Problem 3 3
Fracture 2 2
Device Operates Differently Than Expected 1 1
Coagulation in Device or Device Ingredient 1 1
Component Missing 1 1
Device Markings/Labelling Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48 48
No Clinical Signs, Symptoms or Conditions 21 21
No Consequences Or Impact To Patient 11 11
No Information 4 4
No Code Available 1 1
No Patient Involvement 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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