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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
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
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
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 5
2022 1 1
2023 106 106
2024 422 422
2025 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 509 509
False Negative Result 82 82
No Apparent Adverse Event 16 16
Volume Accuracy Problem 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 4
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 512 512
Insufficient Information 95 98
Unspecified Infection 1 1
Sepsis 1 1
Fever 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Failure 1 1
Phlebitis 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II Aug-08-2024
2 Luminex Corporation II Dec-06-2023
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