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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram-negative bacteria and associated resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Product CodePEN
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 15 15
2022 5 5
2023 1 1
2024 8 8
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 9 9
Incorrect, Inadequate or Imprecise Result or Readings 5 5
False Positive Result 5 5
Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Insufficient Information 2 2
Defective Device 2 2
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Fold 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 8 8
Death 1 1
Drug Resistant Bacterial Infection 1 1
Spinal Column Injury 1 1
Septic Shock 1 1
Cardiogenic Shock 1 1
Renal Failure 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Jul-31-2024
2 BioFire Diagnostics, LLC II Feb-15-2024
3 BioFire Diagnostics, LLC II Dec-01-2023
4 BioFire Diagnostics, LLC II Mar-15-2023
5 BioFire Diagnostics, LLC II Nov-30-2021
6 BioFire Diagnostics, LLC II Aug-12-2021
7 BioFire Diagnostics, LLC II Jun-21-2021
8 BioFire Diagnostics, LLC II Mar-01-2021
9 BioFire Diagnostics, LLC II Jun-08-2020
10 Luminex Corporation II Nov-20-2020
11 Luminex Corporation II Aug-10-2020
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