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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodePJE
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
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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