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TPLC
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show TPLC since
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Device
glucose oxidase, glucose
Regulation Description
Glucose test system.
Product Code
CGA
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT POINT OF CARE INC.
SUBSTANTIALLY EQUIVALENT
3
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
ALERE SAN DIEGO, INC.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
YSI INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
68
68
2021
48
48
2022
276
276
2023
1159
1159
2024
296
296
2025
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
689
689
Wireless Communication Problem
371
371
Incorrect, Inadequate or Imprecise Result or Readings
361
361
Electrical /Electronic Property Problem
191
191
High Test Results
80
80
Low Test Results
52
52
Erratic Results
49
49
Appropriate Term/Code Not Available
37
37
Non Reproducible Results
35
35
Communication or Transmission Problem
24
24
No Apparent Adverse Event
9
9
Low Readings
8
8
Material Integrity Problem
8
8
Battery Problem
7
7
Patient Data Problem
7
7
Failure to Sense
7
7
Insufficient Information
6
6
Problem with Software Installation
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Failure to Power Up
4
4
Unauthorized Access to Computer System
3
3
Material Twisted/Bent
3
3
Inaccurate Information
3
3
Device Alarm System
3
3
Physical Resistance/Sticking
2
2
Display or Visual Feedback Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Output Problem
1
1
Data Problem
1
1
Display Difficult to Read
1
1
Labelling, Instructions for Use or Training Problem
1
1
Incorrect Measurement
1
1
Moisture Damage
1
1
Overheating of Device
1
1
Unable to Obtain Readings
1
1
Component Incompatible
1
1
Obstruction of Flow
1
1
High Readings
1
1
Defective Component
1
1
Expiration Date Error
1
1
Failure to Obtain Sample
1
1
Improper or Incorrect Procedure or Method
1
1
Device Markings/Labelling Problem
1
1
Environmental Compatibility Problem
1
1
Failure of Device to Self-Test
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1705
1705
Hypoglycemia
47
47
Insufficient Information
37
37
Hyperglycemia
27
27
No Consequences Or Impact To Patient
26
26
No Known Impact Or Consequence To Patient
22
22
No Patient Involvement
5
5
Dizziness
5
5
Loss of consciousness
4
4
Shaking/Tremors
4
4
Discomfort
3
3
Fatigue
3
3
Diabetic Ketoacidosis
2
2
Test Result
2
2
Dysphasia
2
2
Distress
1
1
Complaint, Ill-Defined
1
1
Irritability
1
1
No Information
1
1
Convulsion/Seizure
1
1
Nausea
1
1
Respiratory Distress Syndrome of Newborns
1
1
Therapeutic Effects, Unexpected
1
1
Burning Sensation
1
1
Stroke/CVA
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
II
Apr-30-2024
2
Alere San Diego, Inc.
II
Aug-06-2022
3
Mckesson Medical-Surgical Inc. Corporate Office
II
May-27-2025
4
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
III
Sep-14-2022
5
Randox Laboratories Ltd.
II
Oct-31-2023
6
Siemens Healthcare Diagnostics Inc
II
Sep-15-2020
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