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 Code	NTW
Regulation Number	866.4070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	32	32
Leak/Splash	18	18
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Break	10	10
Short Fill	9	9
Device Ingredient or Reagent Problem	6	6
Crack	6	6
Device Markings/Labelling Problem	5	5
Incorrect Or Inadequate Test Results	5	5
Fracture	5	5
Volume Accuracy Problem	4	4
Component Missing	4	4
Coagulation in Device or Device Ingredient	4	4
Fluid/Blood Leak	4	4
Improper or Incorrect Procedure or Method	2	2
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Shipping Damage or Problem	1	1
Backflow	1	1
Material Deformation	1	1
Unexpected Color	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	49	49
No Known Impact Or Consequence To Patient	46	46
No Information	16	16
No Consequences Or Impact To Patient	12	12
Burning Sensation	1	1
Exposure to Body Fluids	1	1
No Patient Involvement	1	1

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