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TPLC
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show TPLC since
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Device
electrode, ion-specific, chloride
Product Code
CGZ
Regulation Number
862.1170
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
2
2
2016
1
1
2017
2
2
2018
19
19
2019
3
3
2020
3
3
2022
5
5
2023
10
10
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
33
33
Low Test Results
16
16
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Non Reproducible Results
11
11
Incorrect Or Inadequate Test Results
4
4
Output Problem
3
3
Mechanical Problem
2
2
Misassembly During Maintenance/Repair
1
1
Material Integrity Problem
1
1
Product Quality Problem
1
1
Incorrect Measurement
1
1
False Device Output
1
1
False Reading From Device Non-Compliance
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28
28
No Consequences Or Impact To Patient
15
15
No Known Impact Or Consequence To Patient
14
14
No Patient Involvement
11
11
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories, Inc
II
May-08-2019
2
OPTI Medical Systems, Inc
II
Jun-14-2011
3
OPTI Medical Systems, Inc
III
Mar-11-2010
4
Ortho-Clinical Diagnostics
II
Nov-01-2019
5
Ortho-Clinical Diagnostics
III
Sep-17-2018
6
Ortho-Clinical Diagnostics
III
Sep-14-2018
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