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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
Regulation Description RNA Preanalytical Systems.
Definition System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing
Product CodeNTW
Regulation Number 866.4070
Device Class 2

MDR Year MDR Reports MDR Events
2020 7 7
2021 12 12
2022 11 11
2023 20 20
2024 12 12
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 12 12
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Break 7 7
Device Ingredient or Reagent Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Fracture 5 5
Crack 4 4
Short Fill 4 4
Fluid/Blood Leak 4 4
Component Missing 3 3
Coagulation in Device or Device Ingredient 3 3
Volume Accuracy Problem 2 2
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Shipping Damage or Problem 1 1
Backflow 1 1
Unexpected Color 1 1
Inaccurate Information 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 1 1

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