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TPLC
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show TPLC since
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Device
electrode, ion specific, potassium
Product Code
CEM
Regulation Number
862.1600
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAMOND DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
DIAMOND DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
EPOCAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INPECO S.P.A.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORP.
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POLYMEDCO, INC.
SUBSTANTIALLY EQUIVALENT
1
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES LTD.
SUBSTANTIALLY EQUIVALENT
1
TOKYO BOEKI MEDISYS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
7
7
2016
6
6
2017
32
32
2018
13
13
2019
25
25
2020
27
27
2021
18
18
2022
16
16
2023
32
32
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
56
56
High Test Results
50
50
Incorrect, Inadequate or Imprecise Result or Readings
16
16
Low Readings
14
14
Mechanical Problem
13
13
Use of Device Problem
12
12
Insufficient Information
12
12
Adverse Event Without Identified Device or Use Problem
7
7
High Readings
7
7
Non Reproducible Results
5
5
Incorrect Or Inadequate Test Results
5
5
Smoking
3
3
Output Problem
3
3
Erratic Results
3
3
Calibration Problem
2
2
Improper Chemical Reaction
2
2
Incorrect Measurement
2
2
Computer Software Problem
2
2
False Device Output
1
1
False Reading From Device Non-Compliance
1
1
Material Fragmentation
1
1
Overheating of Device
1
1
Unable to Obtain Readings
1
1
Break
1
1
Thermal Decomposition of Device
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Device Contamination with Body Fluid
1
1
Failure to Calibrate
1
1
Installation-Related Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanical Jam
1
1
Chemical Problem
1
1
Electrical Shorting
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Component Misassembled
1
1
Sharp Edges
1
1
Unexpected Shutdown
1
1
Misassembled During Installation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
90
90
No Known Impact Or Consequence To Patient
60
60
No Consequences Or Impact To Patient
37
37
Test Result
4
4
Laceration(s)
3
3
Death
3
3
Injury
2
2
Insufficient Information
2
2
No Code Available
1
1
Muscle/Tendon Damage
1
1
Joint Dislocation
1
1
Electric Shock
1
1
Unspecified Infection
1
1
Abrasion
1
1
Exposure to Body Fluids
1
1
Cardiac Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Jun-03-2020
2
Abbott Laboratories
II
Jun-27-2015
3
Beckman Coulter Inc.
II
Aug-10-2013
4
Beckman Coulter Inc.
II
Nov-19-2012
5
Beckman Coulter Inc.
II
Apr-26-2011
6
Beckman Coulter Inc.
II
Mar-09-2011
7
Epocal
II
Feb-06-2009
8
Inpeco S.A.
II
Dec-15-2023
9
Inpeco S.A.
II
May-04-2023
10
Inpeco S.A.
II
Oct-12-2021
11
Inpeco S.A.
II
Nov-06-2020
12
Inpeco S.A.
II
Sep-16-2020
13
Inpeco S.A.
II
Jun-01-2020
14
Inpeco S.A.
II
May-26-2020
15
Inpeco S.A.
II
May-14-2020
16
Inpeco S.A.
II
Nov-16-2016
17
Instrumentation Laboratory Co.
I
Jul-21-2011
18
Ortho-Clinical Diagnostics
II
Nov-01-2019
19
Ortho-Clinical Diagnostics
III
Jun-27-2013
20
Radiometer America Inc
II
Aug-22-2019
21
Radiometer America Inc
II
Apr-28-2011
22
Radiometer America Inc
II
Feb-02-2011
23
Radiometer Medical ApS
II
Jun-15-2021
24
Radiometer Medical ApS
II
Apr-22-2020
25
Randox Laboratories Ltd.
II
Oct-31-2023
26
Randox Laboratories Ltd.
II
Jul-26-2021
27
Roche Diagnostics Corporation
II
May-03-2018
28
Siemens Healthcare Diagnostics, Inc.
II
Apr-07-2015
29
Siemens Healthcare Diagnostics, Inc.
II
Oct-25-2010
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