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Device
coronavirus antigen detection test system.
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Product Code
QKP
Device Class
Not Classified
MDR Year
MDR Reports
MDR Events
2020
1372
1372
2021
6560
6560
2022
13075
13088
2023
3145
3145
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
13317
13321
No Apparent Adverse Event
8852
8852
False Negative Result
5062
5071
Incorrect, Inadequate or Imprecise Result or Readings
2339
2339
Erratic Results
489
489
Non Reproducible Results
408
408
Unable to Obtain Readings
257
257
Use of Device Problem
230
230
No Device Output
102
102
Insufficient Information
92
92
Improper or Incorrect Procedure or Method
75
75
Product Quality Problem
72
72
Device Markings/Labelling Problem
57
57
Adverse Event Without Identified Device or Use Problem
57
57
Component Missing
53
53
Defective Device
39
39
Nonstandard Device
35
35
Manufacturing, Packaging or Shipping Problem
32
32
Appropriate Term/Code Not Available
32
32
Expiration Date Error
21
21
Output Problem
20
20
Patient-Device Incompatibility
16
16
Defective Component
15
15
Leak/Splash
14
14
Labelling, Instructions for Use or Training Problem
13
13
Incorrect Measurement
12
12
Inadequate Instructions for Non-Healthcare Professional
9
9
Therapeutic or Diagnostic Output Failure
8
8
Device Ingredient or Reagent Problem
8
8
Patient Device Interaction Problem
8
8
Missing Information
6
6
Computer System Security Problem
6
6
Obstruction of Flow
6
6
Unexpected Therapeutic Results
5
5
Incomplete or Missing Packaging
5
5
Fluid/Blood Leak
5
5
Contamination
5
5
Material Discolored
4
4
Contamination of Device Ingredient or Reagent
4
4
Material Integrity Problem
4
4
Operating System Becomes Nonfunctional
3
3
Packaging Problem
3
3
Detachment of Device or Device Component
3
3
Contamination /Decontamination Problem
3
3
Crack
3
3
Break
3
3
Material Separation
3
3
Device Difficult to Setup or Prepare
3
3
Unclear Information
3
3
Missing Test Results
3
3
Device Contaminated During Manufacture or Shipping
2
2
Device Handling Problem
2
2
Unsealed Device Packaging
2
2
Poor Quality Image
2
2
Shipping Damage or Problem
2
2
Display or Visual Feedback Problem
2
2
Delivered as Unsterile Product
2
2
Device Emits Odor
2
2
Device Contamination with Chemical or Other Material
2
2
Improper Chemical Reaction
1
1
Improper Flow or Infusion
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
No Flow
1
1
Inadequate User Interface
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Unauthorized Access to Computer System
1
1
Unintended Movement
1
1
Connection Problem
1
1
Fumes or Vapors
1
1
Failure to Obtain Sample
1
1
Application Program Problem
1
1
Application Program Version or Upgrade Problem
1
1
Biocompatibility
1
1
Mechanical Problem
1
1
Fire
1
1
Entrapment of Device
1
1
Display Difficult to Read
1
1
Short Fill
1
1
Microbial Contamination of Device
1
1
Difficult to Remove
1
1
Off-Label Use
1
1
Material Puncture/Hole
1
1
Activation Failure
1
1
Wireless Communication Problem
1
1
Patient Data Problem
1
1
Lack of Effect
1
1
Material Too Soft/Flexible
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
21667
21667
Insufficient Information
3018
3031
No Consequences Or Impact To Patient
1415
1415
Anxiety
126
126
Viral Infection
121
121
No Information
76
76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
68
68
Burning Sensation
46
46
Eye Pain
22
22
Headache
20
20
Red Eye(s)
18
18
Test Result
17
17
Pain
16
16
Hypersensitivity/Allergic reaction
14
14
Cough
12
12
Blurred Vision
11
11
No Patient Involvement
11
11
Sore Throat
10
10
Fever
10
10
Unspecified Eye / Vision Problem
10
10
Unspecified Respiratory Problem
10
10
Skin Inflammation/ Irritation
9
9
Dyspnea
9
9
Malaise
8
8
Epistaxis
8
8
Eye Burn
7
7
Vomiting
6
6
Emotional Changes
6
6
Swelling/ Edema
6
6
No Known Impact Or Consequence To Patient
5
5
Chemical Exposure
5
5
Numbness
4
4
Sneezing
4
4
Diarrhea
4
4
Pneumonia
4
4
Tachycardia
4
4
Taste Disorder
4
4
Distress
3
3
Choking
3
3
Nasal Obstruction
2
2
Decreased Peak Expiratory Flow rate
2
2
Arthralgia
2
2
Urinary Frequency
2
2
Nausea
2
2
Virus
2
2
High Blood Pressure/ Hypertension
2
2
Dysphagia/ Odynophagia
2
2
Conjunctivitis
2
2
Fatigue
2
2
Hemorrhage/Bleeding
2
2
Arrhythmia
2
2
Bacterial Infection
2
2
Foreign Body In Patient
2
2
Skin Burning Sensation
2
2
Localized Skin Lesion
1
1
Convulsion/Seizure
1
1
Contact Dermatitis
1
1
Nodule
1
1
Unspecified Tissue Injury
1
1
Unspecified Ear or Labyrinth Problem
1
1
Unspecified Gastrointestinal Problem
1
1
Renal Impairment
1
1
Unspecified Reproductive System or Breast Problem
1
1
Blister
1
1
Burn(s)
1
1
Cellulitis
1
1
Asthma
1
1
Erythema
1
1
Eye Injury
1
1
Foreign Body Sensation in Eye
1
1
Hypothermia
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Urinary Tract Infection
1
1
Sepsis
1
1
Rash
1
1
Local Reaction
1
1
Visual Impairment
1
1
Chills
1
1
Dizziness
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Depression
1
1
Meningitis
1
1
Reaction
1
1
Weight Changes
1
1
Decreased Sensitivity
1
1
Caustic/Chemical Burns
1
1
Cognitive Changes
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acon Biotech (Hangzhou) Co., Ltd.
II
Apr-15-2022
2
Beckman Coulter Inc.
II
Aug-12-2021
3
Beckman Coulter Inc.
II
May-21-2021
4
CELLTRION USA INC
I
Apr-27-2022
5
CELLTRION USA INC
II
Mar-08-2022
6
CELLTRION USA INC
I
Mar-02-2022
7
CELLTRION USA INC
I
Mar-02-2022
8
CELLTRION USA INC
II
Feb-03-2022
9
Cellex
II
Sep-13-2021
10
Detect Headquarters
II
Jan-04-2023
11
E25Bio, Inc.
I
Feb-09-2022
12
ELLUME LTD
I
Nov-10-2021
13
Empowered Diagnostics LLC
I
Jan-29-2022
14
INNOVA MEDICAL GROUP, INC.
I
Jun-10-2021
15
Jiangsu Well Biotech Co.,Ltd.
I
Oct-08-2022
16
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
I
May-28-2021
17
LUMINOSTICS, INC dba CLIP HEALTH
II
Oct-12-2022
18
LumiraDx
III
Oct-26-2022
19
LumiraDx
II
Mar-26-2021
20
LumiraDx
II
Feb-17-2021
21
Lusys Laboratories, Inc.
I
Mar-10-2022
22
Migo Trading LLC
II
Dec-27-2021
23
North American Diagnostics
I
Jul-29-2022
24
Ortho-Clinical Diagnostics, INc.
II
May-27-2021
25
Ortho-Clinical Diagnostics, Inc.
II
Mar-17-2021
26
Qiagen Sciences LLC
II
Feb-01-2021
27
Quidel Corporation
II
Oct-19-2020
28
SD Biosensor, Inc.
I
May-23-2023
29
SD Biosensor, Inc.
I
Mar-16-2022
30
SML Distribution, LLC
I
May-03-2022
31
Siemens Healthcare Diagnostics, Inc
II
Nov-03-2021
32
USA Medical, LLC
II
May-06-2022
33
Universal Meditech Inc.
I
Jan-27-2023
34
Versea Diagnostics LLC
II
Sep-03-2021
35
WHPM Inc.
II
Apr-07-2022
36
Woodside Acquisitions Inc.
I
May-12-2022
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