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TPLC
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show TPLC since
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2024
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Device
electrode, ion based, enzymatic, creatinine
Product Code
CGL
Regulation Number
862.1225
Device Class
2
Premarket Reviews
Manufacturer
Decision
EPOCAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
4
4
2016
2
2
2017
14
14
2018
11
11
2019
25
25
2020
19
19
2021
20
20
2022
11
11
2023
5
5
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
45
45
Non Reproducible Results
21
21
Incorrect Measurement
13
13
Low Test Results
13
13
False Positive Result
5
5
Low Readings
3
3
High Test Results
3
3
Erratic Results
3
3
Insufficient Information
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Use of Device Problem
2
2
Defective Component
2
2
Incorrect Or Inadequate Test Results
2
2
Device Operates Differently Than Expected
2
2
Fluid/Blood Leak
2
2
Smoking
1
1
Device Stops Intermittently
1
1
Display or Visual Feedback Problem
1
1
Application Program Problem: Dose Calculation Error
1
1
Electrical /Electronic Property Problem
1
1
False Negative Result
1
1
Device Operational Issue
1
1
Device Displays Incorrect Message
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
29
29
No Consequences Or Impact To Patient
20
20
No Information
16
16
No Known Impact Or Consequence To Patient
13
13
Insufficient Information
9
9
Cancer
6
6
No Code Available
4
4
Death
3
3
Abnormal Blood Gases
2
2
Abdominal Pain
2
2
Hematuria
2
2
No Patient Involvement
1
1
Diabetic Ketoacidosis
1
1
Breast Mass
1
1
Premature Labor
1
1
Sudden Cardiac Death
1
1
Claudication
1
1
Apnea
1
1
Breast Cancer
1
1
Cardiac Arrest
1
1
Pain
1
1
Peripheral Vascular Disease
1
1
Transient Ischemic Attack
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Point of Care Inc.
II
Nov-24-2010
2
Nova Biomedical Corporation
II
May-07-2009
3
Radiometer America Inc
II
Mar-18-2015
4
Radiometer America Inc
II
Feb-13-2012
5
Radiometer America Inc
II
Mar-05-2010
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