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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
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
2019 21 21
2020 7 7
2021 12 12
2022 11 11
2023 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Leak/Splash 11 11
Break 9 9
Device Ingredient or Reagent Problem 6 6
Fracture 5 5
Coagulation in Device or Device Ingredient 4 4
Fluid/Blood Leak 4 4
Short Fill 4 4
Device Contamination with Chemical or Other Material 4 4
Component Missing 4 4
Volume Accuracy Problem 3 3
Crack 3 3
Improper or Incorrect Procedure or Method 2 2
Device Markings/Labelling Problem 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Unexpected Color 1 1
Backflow 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 5 5
No Information 3 3
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Qiagen Sciences, Inc. II Jun-28-2019
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