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TPLC
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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
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Low Test Results
6
6
Non Reproducible Results
5
5
High Test Results
4
4
Incorrect Measurement
4
4
Output Problem
2
2
Insufficient Information
1
1
Misassembly During Maintenance/Repair
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
No Consequences Or Impact To Patient
7
7
No Known Impact Or Consequence To Patient
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Roche Diagnostics Operations, Inc.
II
Feb-08-2021
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