Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device gram-negative bacteria and associated resistance markers
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 1
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
ICUBATE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 4 4
2021 15 15
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 7 7
False Positive Result 6 6
False Negative Result 5 5
Output Problem 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Failure to Fold 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 8 8
Death 5 5
Bacterial Infection 2 2
Renal Failure 2 2
Sepsis 1 1
Septic Shock 1 1
Cardiogenic Shock 1 1
Cardiac Arrest 1 1
Unspecified Infection 1 1
Renal Disease, End Stage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Feb-15-2024
2 BioFire Diagnostics, LLC II Dec-01-2023
3 BioFire Diagnostics, LLC II Mar-15-2023
4 BioFire Diagnostics, LLC II Nov-30-2021
5 BioFire Diagnostics, LLC II Aug-12-2021
6 BioFire Diagnostics, LLC II Jun-21-2021
7 BioFire Diagnostics, LLC II Mar-01-2021
8 BioFire Diagnostics, LLC II Jun-08-2020
9 BioFire Diagnostics, LLC II Apr-12-2019
10 Luminex Corporation II Nov-20-2020
11 Luminex Corporation II Aug-10-2020
-
-