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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
Electrical /Electronic Property Problem
26
26
Smoking
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
Missing Information
6
6
Use of Device Problem
6
6
Data Problem
5
5
Power Problem
4
4
Device Operates Differently Than Expected
4
4
Device Markings/Labelling Problem
4
4
Loss of Power
3
3
Failure To Run On AC/DC
3
3
Out-Of-Box Failure
3
3
Failure to Power Up
3
3
Defective Device
3
3
Display Difficult to Read
3
3
Device Difficult to Setup or Prepare
2
2
Computer Operating System Problem
2
2
Optical Problem
2
2
Incorrect Measurement
2
2
Computer Software Problem
2
2
Mechanical Problem
2
2
Device Stops Intermittently
2
2
Display or Visual Feedback Problem
2
2
Loose or Intermittent Connection
2
2
Sparking
2
2
Device Displays Incorrect Message
2
2
No Device Output
2
2
False Reading From Device Non-Compliance
1
1
High Readings
1
1
Missing Test Results
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Calibration Problem
1
1
Device Handling Problem
1
1
Unsealed Device Packaging
1
1
Device Emits Odor
1
1
Power Conditioning Problem
1
1
Inadequate Service
1
1
Low Readings
1
1
Programming Issue
1
1
No Apparent Adverse Event
1
1
Insufficient Information
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
Urinary Tract Infection
1
1
Distress
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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