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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device counter, cell, automated (particle counter)
Product CodeGKL
Regulation Number 864.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRIS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2018 2 2
2020 13 13
2021 11 11
2022 7 7
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 21 21
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Leak/Splash 3 3
Device Handling Problem 2 2
Illegible Information 2 2
Mechanical Problem 1 1
Smoking 1 1
Incorrect Or Inadequate Test Results 1 1
Insufficient Information 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 6 6
No Patient Involvement 4 4
No Known Impact Or Consequence To Patient 3 3
Test Result 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Instruments, LLC II Dec-19-2018
2 BD Biosciences, Systems & Reagents II Jan-20-2015
3 Beckman Coulter Inc. II Apr-12-2011
4 Becton, Dickinson and Company, BD Biosciences III Apr-14-2016
5 Siemens Healthcare Diagnostics II Aug-28-2013
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