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TPLC
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Device
blood/plasma collection device for dna testing
Definition
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Product Code
PJE
Regulation Number
862.1675
Device Class
2
Premarket Reviews
Manufacturer
Decision
PREANALYTIX GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
12
12
2020
3
3
2021
14
14
2022
16
16
2023
63
63
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Ingredient or Reagent Problem
42
42
Device Contamination with Chemical or Other Material
25
25
Incorrect, Inadequate or Imprecise Result or Readings
21
21
Short Fill
13
13
Volume Accuracy Problem
6
6
Material Deformation
3
3
Fluid/Blood Leak
3
3
Fracture
3
3
Leak/Splash
2
2
Crack
2
2
Material Discolored
2
2
Improper or Incorrect Procedure or Method
2
2
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Difficult or Delayed Activation
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Separation Problem
1
1
Missing Information
1
1
Break
1
1
Coagulation in Device or Device Ingredient
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
102
102
No Known Impact Or Consequence To Patient
10
10
No Patient Involvement
2
2
No Consequences Or Impact To Patient
1
1
No Information
1
1
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