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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram-positive bacteria and their resistance markers
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product CodePAM
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
GREAT BASIN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICUBATE, INC
  SUBSTANTIALLY EQUIVALENT 1
NANOSPHERE, INC
  SUBSTANTIALLY EQUIVALENT 1
  GRANTED 1

MDR Year MDR Reports MDR Events
2015 1 1
2020 2 2
2021 2 2
2022 1 1
2023 106 106
2024 369 369

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 419 419
False Negative Result 46 46
No Apparent Adverse Event 15 15
Volume Accuracy Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
Insufficient Information 49 49
Unspecified Infection 1 1
Death 1 1
Sepsis 1 1
Fever 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Failure 1 1
Toxicity 1 1
Phlebitis 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, Inc. II Jun-20-2014
2 BioFire Diagnostics, LLC II Oct-30-2018
3 Great Basin Scientific, Inc. II Jan-19-2017
4 Luminex Corporation II Aug-08-2024
5 Luminex Corporation II Dec-06-2023
6 Luminex Corporation II Nov-20-2020
7 Luminex Corporation II Aug-10-2020
8 Luminex Corporation III Feb-11-2019
9 Luminex Corporation II Nov-10-2018
10 Nanosphere, Inc. II Sep-30-2014
11 Nanosphere, Inc. II Sep-23-2014
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