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TPLC
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show TPLC since
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Device
glucose oxidase, glucose
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
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
116
116
2020
68
68
2021
48
48
2022
276
276
2023
1159
1159
2024
72
72
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
677
677
Wireless Communication Problem
355
355
Incorrect, Inadequate or Imprecise Result or Readings
303
303
Electrical /Electronic Property Problem
232
232
Appropriate Term/Code Not Available
38
38
High Test Results
37
37
Non Reproducible Results
34
34
Low Test Results
31
31
Communication or Transmission Problem
24
24
Low Readings
10
10
No Apparent Adverse Event
8
8
Battery Problem
7
7
Patient Data Problem
7
7
Failure to Sense
7
7
Material Integrity Problem
6
6
Insufficient Information
6
6
Problem with Software Installation
4
4
Failure to Power Up
4
4
Device Alarm System
4
4
Overheating of Device
3
3
Peeled/Delaminated
3
3
Material Twisted/Bent
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Unauthorized Access to Computer System
3
3
Inaccurate Information
3
3
Physical Resistance/Sticking
3
3
Failure to Obtain Sample
2
2
Image Display Error/Artifact
2
2
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Incorrect Measurement
1
1
Moisture Damage
1
1
Component Incompatible
1
1
Display Difficult to Read
1
1
Display or Visual Feedback Problem
1
1
Unable to Obtain Readings
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Obstruction of Flow
1
1
Device Displays Incorrect Message
1
1
Therapeutic or Diagnostic Output Failure
1
1
Output Problem
1
1
Expiration Date Error
1
1
Device Markings/Labelling Problem
1
1
Environmental Compatibility Problem
1
1
Failure of Device to Self-Test
1
1
Erratic Results
1
1
Explosion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1474
1474
No Known Impact Or Consequence To Patient
82
82
No Consequences Or Impact To Patient
61
61
Insufficient Information
36
36
Hypoglycemia
28
28
Hyperglycemia
23
23
No Patient Involvement
16
16
Shaking/Tremors
7
7
Dizziness
4
4
Discomfort
3
3
Nausea
3
3
Fatigue
3
3
Dysphasia
2
2
Weakness
2
2
Loss of consciousness
2
2
Test Result
2
2
No Information
1
1
Irritability
1
1
Sweating
1
1
Anxiety
1
1
Distress
1
1
Confusion/ Disorientation
1
1
Lethargy
1
1
Chemical Exposure
1
1
Polydipsia
1
1
Burning Sensation
1
1
Complaint, Ill-Defined
1
1
Hypoesthesia
1
1
Diabetic Ketoacidosis
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Syncope
1
1
Endophthalmitis
1
1
Respiratory Distress Syndrome of Newborns
1
1
Therapeutic Effects, Unexpected
1
1
Visual Impairment
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
II
Aug-06-2022
2
Medline Industries Inc
II
Nov-22-2019
3
Ortho-Clinical Diagnostics
II
Aug-06-2019
4
Polymer Technology Systems, Inc.
II
May-23-2019
5
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
III
Sep-14-2022
6
Randox Laboratories Ltd.
II
Oct-31-2023
7
Siemens Healthcare Diagnostics Inc
II
Sep-15-2020
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