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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Product CodeNQX
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 2
  1.  K162444  Xpert MRSA NxG
  2.  K190771  Xpert MRSA/SA Blood Culture, GeneXpert Dx System, ...
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2
2021 3 3
2022 5 5
2023 12 12
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 21 21
False Positive Result 4 4
No Apparent Adverse Event 2 2
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Death 1 1
Sepsis 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-22-2019
2 Cepheid II Aug-16-2016
3 Roche Molecular Systems, Inc. II Mar-26-2018
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