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TPLC
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Device
alkaline picrate, colorimetry, creatinine
Product Code
CGX
Regulation Number
862.1225
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
1. K210452
Creatinine2
MDR Year
MDR Reports
MDR Events
2019
25
25
2020
19
19
2021
13
13
2022
23
23
2023
20
20
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
86
86
Low Test Results
15
15
Non Reproducible Results
14
14
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Inaccurate Information
2
2
Labelling, Instructions for Use or Training Problem
2
2
Incorrect Measurement
2
2
High Readings
1
1
Low Readings
1
1
Improper Flow or Infusion
1
1
Material Integrity Problem
1
1
Output Problem
1
1
Pressure Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
70
70
No Known Impact Or Consequence To Patient
37
37
No Consequences Or Impact To Patient
8
8
Insufficient Information
2
2
Exposure to Body Fluids
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
2
Siemens Healthcare Diagnostics, Inc.
II
Jun-26-2020
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