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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device meningitis/encephalitis pathogen multiplex nucleic acid detection system
Regulation Description Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
Definition A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
Product CodePLO
Regulation Number 866.3970
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX SA
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 3 3
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
False Positive Result 4 4
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 5 5
Meningitis 2 2
Encephalitis 1 1
No Information 1 1
Neurological Deficit/Dysfunction 1 1
Coma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Nov-10-2018
2 DiaSorin Molecular LLC II Jul-10-2020
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