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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
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
40
41
False Positive Result
18
113
Incorrect, Inadequate or Imprecise Result or Readings
13
13
High Test Results
13
13
Non Reproducible Results
13
14
Patient Data Problem
8
8
Electrical /Electronic Property Problem
6
6
Incorrect Measurement
6
6
Fire
4
4
Smoking
2
2
Output Problem
2
2
Insufficient Information
2
2
Communication or Transmission Problem
2
2
Computer Operating System Problem
2
2
Electrical Shorting
1
1
Mechanical Jam
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Optical Obstruction
1
1
Delayed Program or Algorithm Execution
1
1
Use of Device Problem
1
1
Computer Software Problem
1
1
Low Test Results
1
1
High Readings
1
1
Low Readings
1
1
Device Displays Incorrect Message
1
1
Leak/Splash
1
1
Misfocusing
1
1
No Device Output
1
1
Unable to Obtain Readings
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
40
40
No Known Impact Or Consequence To Patient
15
112
Urinary Tract Infection
14
14
No Patient Involvement
3
3
No Information
3
3
Insufficient Information
3
3
Test Result
1
1
Chemical Exposure
1
1
Bacterial Infection
1
1
Burn(s)
1
1
Eye Injury
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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