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TPLC
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show TPLC since
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Device
counter, cell, automated (particle counter)
Product Code
GKL
Regulation Number
864.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Illegible Information
2
2
Device Handling Problem
2
2
Smoking
1
1
Mechanical Problem
1
1
Insufficient Information
1
1
Incorrect Or Inadequate Test Results
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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