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TPLC
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show TPLC since
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Device
automated urinalysis system
Product Code
KQO
Regulation Number
862.2900
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
64
83
2020
21
99
2021
13
13
2022
15
15
2023
19
19
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
41
42
False Positive Result
18
113
Non Reproducible Results
13
14
Incorrect, Inadequate or Imprecise Result or Readings
13
13
High Test Results
13
13
Patient Data Problem
8
8
Electrical /Electronic Property Problem
6
6
Incorrect Measurement
6
6
Fire
4
4
Communication or Transmission Problem
2
2
Output Problem
2
2
Insufficient Information
2
2
Smoking
2
2
Computer Operating System Problem
2
2
Low Test Results
2
2
No Device Output
2
2
Mechanical Jam
1
1
Device Displays Incorrect Message
1
1
Leak/Splash
1
1
High Readings
1
1
Unable to Obtain Readings
1
1
Use of Device Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Low Readings
1
1
Electrical Shorting
1
1
Computer Software Problem
1
1
Delayed Program or Algorithm Execution
1
1
Optical Obstruction
1
1
Misfocusing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
53
53
No Clinical Signs, Symptoms or Conditions
43
43
No Known Impact Or Consequence To Patient
15
112
Urinary Tract Infection
14
14
No Information
3
3
No Patient Involvement
3
3
Insufficient Information
3
3
Test Result
1
1
Chemical Exposure
1
1
Burn(s)
1
1
Eye Injury
1
1
Bacterial Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arkray Factory USA, Inc.
II
Jun-20-2019
2
Beckman Coulter Inc.
II
May-09-2020
3
Beckman Coulter Inc.
II
Jan-29-2020
4
Beckman Coulter Inc.
II
Jan-23-2020
5
Beckman Coulter Inc.
II
Jul-03-2019
6
Beckman Coulter, Inc.
II
May-17-2023
7
Beckman Coulter, Inc.
II
Mar-20-2020
8
Roche Diagnostics Operations, Inc.
II
Nov-18-2021
9
Sysmex America, Inc.
II
Apr-15-2020
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