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TPLC
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show TPLC since
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Device
method, enzymatic, glucose (urinary, non-quantitative)
Product Code
JIL
Regulation Number
862.1340
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ARKRAY INC.
SUBSTANTIALLY EQUIVALENT
1
ARKRAY, INC.
SUBSTANTIALLY EQUIVALENT
1
DFI CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
HEALTHY.IO LTD
SUBSTANTIALLY EQUIVALENT
1
IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL INC
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SCANADU, INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
TECO DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
3
TECO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
47
47
2015
45
45
2016
40
40
2017
33
33
2018
68
68
2019
67
67
2020
23
23
2021
12
12
2022
14
14
2023
15
15
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
113
113
Low Test Results
38
38
High Test Results
29
29
False Positive Result
28
28
Smoking
26
26
Electrical /Electronic Property Problem
26
26
Break
23
23
Nonstandard Device
22
22
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Non Reproducible Results
13
13
Patient Data Problem
8
8
Incorrect Or Inadequate Test Results
7
7
Use of Device Problem
6
6
Missing Information
6
6
Data Problem
5
5
Device Operates Differently Than Expected
4
4
Power Problem
4
4
Device Markings/Labelling Problem
4
4
Display Difficult to Read
3
3
Failure to Power Up
3
3
Defective Device
3
3
Out-Of-Box Failure
3
3
Failure To Run On AC/DC
3
3
Loss of Power
3
3
Computer Software Problem
2
2
Computer Operating System Problem
2
2
Optical Problem
2
2
Device Difficult to Setup or Prepare
2
2
No Device Output
2
2
Display or Visual Feedback Problem
2
2
Device Displays Incorrect Message
2
2
Loose or Intermittent Connection
2
2
Device Stops Intermittently
2
2
Incorrect Measurement
2
2
Mechanical Problem
2
2
Sparking
2
2
Overheating of Device
1
1
Connection Problem
1
1
No Apparent Adverse Event
1
1
Low Readings
1
1
Power Conditioning Problem
1
1
Temperature Problem
1
1
Inadequate Service
1
1
Programming Issue
1
1
High Readings
1
1
False Reading From Device Non-Compliance
1
1
Device Emits Odor
1
1
Missing Test Results
1
1
Unsealed Device Packaging
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
200
200
No Known Impact Or Consequence To Patient
84
84
No Clinical Signs, Symptoms or Conditions
61
61
No Patient Involvement
26
26
Pregnancy
5
5
Not Applicable
3
3
Insufficient Information
2
2
Patient Problem/Medical Problem
1
1
Irritation
1
1
Exposure to Body Fluids
1
1
Urinary Frequency
1
1
Distress
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jan-13-2016
2
Macherey Nagel Gmbh & Co. Kg
II
May-16-2024
3
Roche Diagnostics Operations, Inc.
II
Oct-25-2016
4
Siemens Healthcare Diagnostics, Inc
II
Oct-17-2014
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