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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
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 2
ICUBATE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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

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
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 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 13 13
Insufficient Information 8 8
Death 5 5
Bacterial Infection 2 2
Renal Failure 2 2
Septic Shock 1 1
Renal Disease, End Stage 1 1
Sepsis 1 1
Cardiac Arrest 1 1
Unspecified Infection 1 1
Cardiogenic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Nov-30-2021
2 BioFire Diagnostics, LLC II Aug-12-2021
3 BioFire Diagnostics, LLC II Jun-21-2021
4 BioFire Diagnostics, LLC II Mar-01-2021
5 BioFire Diagnostics, LLC II Jun-08-2020
6 BioFire Diagnostics, LLC II Apr-12-2019
7 BioFire Diagnostics, LLC II Apr-25-2018
8 Luminex Corporation II Nov-20-2020
9 Luminex Corporation II Aug-10-2020
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