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TPLC
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show TPLC since
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2024
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Device
enzymatic method, ammonia
Product Code
JIF
Regulation Number
862.1065
Device Class
1
Premarket Reviews
Manufacturer
Decision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
3
3
2016
4
4
2017
7
7
2018
1
1
2019
1
1
2020
1
1
2021
1
1
2022
2
2
2023
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
12
12
Low Test Results
7
7
Non Reproducible Results
4
4
Incorrect Or Inadequate Test Results
4
4
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Visual Prompts will not Clear
2
2
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
12
12
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
3
3
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Apr-16-2012
2
RANDOX LABORATORIES, LTD.
II
Sep-14-2020
3
Sekisui Diagnostics P.E.I. Inc.
II
Jan-23-2017
4
Sentinel CH SpA
II
Oct-26-2015
5
Siemens Healthcare Diagnostics, Inc.
II
Oct-11-2018
6
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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