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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
3478
3478
2024
464
464
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
13550
13554
No Apparent Adverse Event
9072
9072
False Negative Result
5317
5326
Incorrect, Inadequate or Imprecise Result or Readings
2341
2341
Erratic Results
492
492
Non Reproducible Results
449
449
Unable to Obtain Readings
333
333
Use of Device Problem
231
231
Insufficient Information
111
111
Improper or Incorrect Procedure or Method
105
105
No Device Output
102
102
Product Quality Problem
72
72
Adverse Event Without Identified Device or Use Problem
59
59
Device Markings/Labelling 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
Output Problem
27
27
Expiration Date Error
21
21
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
Device Ingredient or Reagent Problem
8
8
Therapeutic or Diagnostic Output Failure
8
8
Patient Device Interaction Problem
8
8
Missing Information
6
6
Obstruction of Flow
6
6
Computer System Security Problem
6
6
Fluid/Blood Leak
6
6
Contamination
5
5
Incomplete or Missing Packaging
5
5
Unexpected Therapeutic Results
5
5
Contamination of Device Ingredient or Reagent
4
4
Detachment of Device or Device Component
4
4
Material Integrity Problem
4
4
Material Discolored
4
4
Crack
3
3
Break
3
3
Material Separation
3
3
Poor Quality Image
3
3
Device Difficult to Setup or Prepare
3
3
Operating System Becomes Nonfunctional
3
3
Packaging Problem
3
3
Contamination /Decontamination Problem
3
3
Unclear Information
3
3
Missing Test Results
3
3
Device Handling Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Contamination with Chemical or Other Material
2
2
Unsealed Device Packaging
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
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
Off-Label Use
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
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
Inadequate User Interface
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
No Flow
1
1
Fumes or Vapors
1
1
Failure to Obtain Sample
1
1
Connection Problem
1
1
Unraveled Material
1
1
Application Program Problem
1
1
Application Program Version or Upgrade Problem
1
1
Biocompatibility
1
1
Lack of Effect
1
1
Material Too Soft/Flexible
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Inaccurate Information
1
1
Activation Failure
1
1
Wireless Communication Problem
1
1
Unauthorized Access to Computer System
1
1
Unintended Movement
1
1
Patient Data Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22283
22283
Insufficient Information
3175
3188
No Consequences Or Impact To Patient
1415
1415
Viral Infection
133
133
Anxiety
126
126
No Information
76
76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
68
68
Burning Sensation
50
50
Eye Pain
25
25
Headache
22
22
Red Eye(s)
20
20
Test Result
17
17
Pain
16
16
Hypersensitivity/Allergic reaction
14
14
Cough
12
12
No Patient Involvement
11
11
Fever
11
11
Blurred Vision
11
11
Sore Throat
11
11
Unspecified Eye / Vision Problem
10
10
Unspecified Respiratory Problem
10
10
Skin Inflammation/ Irritation
9
9
Malaise
9
9
Dyspnea
9
9
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
Taste Disorder
5
5
Chemical Exposure
5
5
Numbness
4
4
Tachycardia
4
4
Sneezing
4
4
Diarrhea
4
4
Pneumonia
4
4
Nausea
3
3
Distress
3
3
Choking
3
3
Foreign Body In Patient
3
3
Skin Burning Sensation
3
3
Nasal Obstruction
2
2
Decreased Peak Expiratory Flow rate
2
2
Dizziness
2
2
Arthralgia
2
2
Urinary Frequency
2
2
Virus
2
2
Fatigue
2
2
High Blood Pressure/ Hypertension
2
2
Dysphagia/ Odynophagia
2
2
Conjunctivitis
2
2
Arrhythmia
2
2
Bacterial Infection
2
2
Hemorrhage/Bleeding
2
2
Foreign Body Sensation in Eye
1
1
Erythema
1
1
Eye Injury
1
1
Burn(s)
1
1
Cellulitis
1
1
Asthma
1
1
Abdominal Pain
1
1
Hypothermia
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Sepsis
1
1
Rash
1
1
Local Reaction
1
1
Chills
1
1
Urinary Tract Infection
1
1
Visual Impairment
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Depression
1
1
Meningitis
1
1
Reaction
1
1
Weight Changes
1
1
Caustic/Chemical Burns
1
1
Cognitive Changes
1
1
Lethargy
1
1
Localized Skin Lesion
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
Decreased Sensitivity
1
1
Convulsion/Seizure
1
1
Contact Dermatitis
1
1
Nodule
1
1
Unspecified Tissue Injury
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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