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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
6561
6561
2022
13082
13095
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
11864
11868
No Apparent Adverse Event
7545
7545
False Negative Result
4301
4310
Incorrect, Inadequate or Imprecise Result or Readings
2280
2280
Erratic Results
346
346
Non Reproducible Results
345
345
Use of Device Problem
220
220
Product Quality Problem
60
60
Insufficient Information
57
57
Adverse Event Without Identified Device or Use Problem
52
52
Component Missing
46
46
Device Markings/Labelling Problem
38
38
Appropriate Term/Code Not Available
32
32
Improper or Incorrect Procedure or Method
26
26
Nonstandard Device
24
24
Defective Device
22
22
Manufacturing, Packaging or Shipping Problem
21
21
Output Problem
20
20
Patient-Device Incompatibility
16
16
Defective Component
14
14
Leak/Splash
13
13
Expiration Date Error
12
12
Labelling, Instructions for Use or Training Problem
10
10
Unable to Obtain Readings
7
7
Inadequate Instructions for Non-Healthcare Professional
7
7
Therapeutic or Diagnostic Output Failure
7
7
Patient Device Interaction Problem
6
6
Computer System Security Problem
6
6
Missing Information
6
6
Unexpected Therapeutic Results
5
5
Incorrect Measurement
5
5
Fluid/Blood Leak
4
4
Incomplete or Missing Packaging
4
4
No Device Output
4
4
Unsealed Device Packaging
3
3
Obstruction of Flow
3
3
Break
3
3
Contamination
3
3
Material Discolored
3
3
Contamination of Device Ingredient or Reagent
3
3
Detachment of Device or Device Component
3
3
Device Ingredient or Reagent Problem
3
3
Device Contamination with Chemical or Other Material
2
2
Packaging Problem
2
2
Operating System Becomes Nonfunctional
2
2
Material Integrity Problem
2
2
Contamination /Decontamination Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Crack
2
2
Display or Visual Feedback Problem
2
2
Poor Quality Image
2
2
Device Emits Odor
2
2
Material Separation
2
2
Shipping Damage or Problem
2
2
Missing Test Results
2
2
Application Program Freezes, Becomes Nonfunctional
1
1
Inaccurate Information
1
1
Lack of Effect
1
1
Short Fill
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Delivered as Unsterile Product
1
1
Mechanical Problem
1
1
Entrapment of Device
1
1
Fire
1
1
Display Difficult to Read
1
1
No Flow
1
1
Protective Measures Problem
1
1
Material Too Soft/Flexible
1
1
Unauthorized Access to Computer System
1
1
Unintended Movement
1
1
Patient Data Problem
1
1
Device Handling Problem
1
1
Improper Chemical Reaction
1
1
Inadequate User Interface
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
19463
19463
Insufficient Information
2071
2084
No Consequences Or Impact To Patient
1415
1415
Anxiety
126
126
Viral Infection
84
84
No Information
76
76
Burning Sensation
43
43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
38
38
Headache
21
21
Eye Pain
18
18
Test Result
17
17
Red Eye(s)
16
16
Pain
16
16
Hypersensitivity/Allergic reaction
13
13
Blurred Vision
11
11
No Patient Involvement
11
11
Fever
10
10
Sore Throat
8
8
Eye Burn
7
7
Cough
7
7
Epistaxis
7
7
Skin Inflammation/ Irritation
7
7
Swelling/ Edema
6
6
Unspecified Eye / Vision Problem
6
6
Emotional Changes
6
6
Unspecified Respiratory Problem
5
5
No Known Impact Or Consequence To Patient
5
5
Numbness
4
4
Diarrhea
4
4
Pneumonia
4
4
Vomiting
3
3
Chemical Exposure
3
3
Taste Disorder
3
3
Nasal Obstruction
2
2
Foreign Body In Patient
2
2
Dizziness
2
2
Urinary Frequency
2
2
Distress
2
2
Arthralgia
2
2
Malaise
2
2
Fatigue
2
2
Virus
2
2
Hemorrhage/Bleeding
2
2
High Blood Pressure/ Hypertension
2
2
Hypothermia
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Nausea
1
1
Dyspnea
1
1
Asthma
1
1
Bacterial Infection
1
1
Burn(s)
1
1
Erythema
1
1
Eye Injury
1
1
Foreign Body Sensation in Eye
1
1
Sepsis
1
1
Urinary Tract Infection
1
1
Rash
1
1
Local Reaction
1
1
Chills
1
1
Sneezing
1
1
Depression
1
1
Meningitis
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Reaction
1
1
Caustic/Chemical Burns
1
1
Cognitive Changes
1
1
Lethargy
1
1
Weight Changes
1
1
Convulsion/Seizure
1
1
Unspecified Ear or Labyrinth Problem
1
1
Unspecified Gastrointestinal Problem
1
1
Renal Impairment
1
1
Blister
1
1
Skin Burning Sensation
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
Mar-16-2022
29
SML Distribution, LLC
I
May-03-2022
30
Siemens Healthcare Diagnostics, Inc
II
Nov-03-2021
31
USA Medical, LLC
II
May-06-2022
32
Universal Meditech Inc.
I
Jan-27-2023
33
Versea Diagnostics LLC
II
Sep-03-2021
34
WHPM Inc.
II
Apr-07-2022
35
Woodside Acquisitions Inc.
I
May-12-2022
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