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TPLC
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show TPLC since
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Device
acid, lactic, enzymatic method
Product Code
KHP
Regulation Number
862.1450
Device Class
1
Premarket Reviews
Manufacturer
Decision
ABAXIS, INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT PONT OF CARE INC
SUBSTANTIALLY EQUIVALENT
1
EPOCAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
19
19
2015
12
12
2016
41
41
2017
9
9
2018
12
12
2019
10
10
2020
6
6
2021
3
3
2022
7
7
2023
3
3
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
39
39
Incorrect, Inadequate or Imprecise Result or Readings
38
38
High Test Results
34
34
Incorrect Or Inadequate Test Results
12
12
Calibration Problem
10
10
Device Displays Incorrect Message
5
5
High Readings
4
4
Low Readings
3
3
Improper or Incorrect Procedure or Method
3
3
False Negative Result
3
3
Insufficient Information
3
3
Non Reproducible Results
3
3
Display Difficult to Read
2
2
Maintenance Does Not Comply To Manufacturers Recommendations
2
2
Device Operates Differently Than Expected
2
2
Patient Data Problem
1
1
Product Quality Problem
1
1
No Apparent Adverse Event
1
1
Communication or Transmission Problem
1
1
No Display/Image
1
1
Erratic Results
1
1
Computer Operating System Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
54
54
No Consequences Or Impact To Patient
21
21
No Clinical Signs, Symptoms or Conditions
17
17
No Information
15
15
Misdiagnosis
8
8
Abdominal Pain
2
2
No Code Available
2
2
Pneumonia
2
2
Renal Failure
2
2
High Blood Pressure/ Hypertension
1
1
Syncope/Fainting
1
1
Intraocular Pressure Increased
1
1
Adult Respiratory Distress Syndrome
1
1
Sepsis
1
1
Gastroesophageal Burn
1
1
Diabetic Ketoacidosis
1
1
Overdose
1
1
Fever
1
1
Injury
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Dehydration
1
1
Fall
1
1
Pain
1
1
Hypoglycemia
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Nov-09-2016
2
Abbott Point Of Care Inc.
II
Feb-18-2020
3
Beckman Coulter Inc.
II
Jun-08-2016
4
Beckman Coulter Inc.
II
Jan-28-2015
5
Beckman Coulter Inc.
II
Jun-27-2013
6
Beckman Coulter Inc.
II
May-24-2013
7
Horiba Instruments Inc
II
Feb-02-2016
8
Ortho-Clinical Diagnostics
II
Oct-17-2016
9
Radiometer America Inc
II
Sep-30-2013
10
Roche Diagnostics Corporation
II
Apr-13-2019
11
Siemens Healthcare Diagnostics Inc
III
Aug-19-2016
12
Siemens Healthcare Diagnostics Inc
II
Sep-24-2015
13
Siemens Healthcare Diagnostics Inc
II
Aug-28-2015
14
Siemens Healthcare Diagnostics Inc
II
Jul-18-2014
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