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	31	31
Leak/Splash	16	16
Incorrect, Inadequate or Imprecise Result or Readings	15	15
Break	10	10
Short Fill	8	8
Crack	6	6
Device Ingredient or Reagent Problem	6	6
Device Markings/Labelling Problem	5	5
Fracture	5	5
Incorrect Or Inadequate Test Results	5	5
Component Missing	4	4
Volume Accuracy Problem	4	4
Fluid/Blood Leak	4	4
Coagulation in Device or Device Ingredient	4	4
Improper or Incorrect Procedure or Method	2	2
Material Deformation	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 Known Impact Or Consequence To Patient	46	46
No Clinical Signs, Symptoms or Conditions	44	44
No Information	16	16
No Consequences Or Impact To Patient	12	12
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