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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointestinal pathogen panel multiplex nucleic acid-based assay system
Regulation Description Gastrointestinal microorganism multiplex nucleic acid-based assay.
Definition A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Product CodePCH
Regulation Number 866.3990
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED BIOCODE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GENETIC SIGNATURES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN GMBH
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 26 26
2022 47 49
2023 62 62
2024 45 45
2025 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 168 169
Incorrect, Inadequate or Imprecise Result or Readings 28 29
False Negative Result 13 13
Non Reproducible Results 2 2
Chemical Problem 1 1
Product Quality Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 201
Insufficient Information 16 16
Diarrhea 3 3
No Consequences Or Impact To Patient 3 3
Stroke/CVA 1 1
Sepsis 1 1
Fever 1 1
Chills 1 1
Vomiting 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Sep-30-2024
2 BioFire Diagnostics, LLC II Aug-06-2024
3 BioFire Diagnostics, LLC II Feb-15-2024
4 BioFire Diagnostics, LLC II Jan-10-2024
5 BioFire Diagnostics, LLC II Apr-14-2023
6 BioFire Diagnostics, LLC II Mar-15-2023
7 BioFire Diagnostics, LLC II Mar-06-2020
8 GET TESTED INTERNATIONAL AB II Dec-01-2025
9 Luminex Corporation II Jun-28-2023
10 Luminex Corporation II Jul-06-2022
11 Luminex Corporation II Sep-10-2021
12 Luminex Corporation II Apr-23-2021
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