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TPLC
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show TPLC since
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Device
electrode, ion specific, calcium
Product Code
JFP
Regulation Number
862.1145
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT POINT OF CARE INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
3
3
2017
2
2
2018
5
5
2019
6
6
2020
6
6
2022
6
6
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
10
10
High Test Results
8
8
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Non Reproducible Results
5
5
Incorrect Measurement
4
4
Incorrect Or Inadequate Test Results
3
3
Output Problem
2
2
Insufficient Information
1
1
Environmental Compatibility Problem
1
1
Misassembly During Maintenance/Repair
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
14
14
No Clinical Signs, Symptoms or Conditions
12
12
No Known Impact Or Consequence To Patient
8
8
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Radiometer America Inc
II
Jun-16-2011
2
Roche Diagnostics Operations, Inc.
II
Feb-08-2021
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