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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
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Electrical /Electronic Property Problem 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 4 4
Renal Failure 2 2
Sepsis 1 1
Renal Disease, End Stage 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Jun-08-2020
2 BioFire Diagnostics, LLC II Apr-12-2019
3 BioFire Diagnostics, LLC II Apr-25-2018
4 Luminex Corporation II Aug-10-2020
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