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TPLC - Total Product Life Cycle
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Device respiratory virus panel nucleic acid assay system
Definition A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Product CodeOCC
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED BIOCODE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 2 2
2020 17 17
2021 686 686
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 691 691
Incorrect, Inadequate or Imprecise Result or Readings 296 296
Output Problem 269 269
Unable to Obtain Readings 10 10
Non Reproducible Results 7 7
Adverse Event Without Identified Device or Use Problem 1 1
Optical Obstruction 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 679 679
Anxiety 642 642
Unspecified Respiratory Problem 629 629
No Consequences Or Impact To Patient 87 87
Insufficient Information 19 19
Respiratory Tract Infection 14 14
Test Result 2 2
Death 2 2
Dyspnea 2 2
Fatigue 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Nausea 1 1
Pneumonia 1 1
Sepsis 1 1
Weakness 1 1
Chills 1 1
Cough 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Viral Infection 1 1
Bronchopneumonia 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DiaSorin Molecular LLC II Mar-03-2023
2 Hologic, Inc II May-28-2020
3 Luminex Corporation II Jul-02-2021
4 Luminex Corporation II Oct-05-2020
5 Luminex Molecular Diagnostics II Oct-18-2019
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