Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
reagents, 2019-novel coronavirus nucleic acid
Definition
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.
Product Code
QJR
Device Class
Not Classified
MDR Year
MDR Reports
MDR Events
2020
1636
1637
2021
7309
7317
2022
2014
2018
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
6953
6961
Incorrect, Inadequate or Imprecise Resultor Readings
3353
3353
Output Problem
2557
2557
Non Reproducible Results
1991
1991
False Negative Result
1430
1430
No Apparent Adverse Event
237
238
Nonstandard Device
72
72
Off-Label Use
59
59
Erratic Results
39
39
Unable to Obtain Readings
28
28
Use of Device Problem
26
26
Adverse Event Without Identified Device or Use Problem
24
24
Device Contaminated at the User Facility
23
23
Improper or Incorrect Procedure or Method
23
23
Insufficient Information
19
19
Low Readings
13
13
Application Program Problem
9
9
Device Markings/Labelling Problem
8
8
Contamination
8
8
Patient-Device Incompatibility
6
6
Optical Obstruction
6
6
Patient Device Interaction Problem
5
5
Therapeutic or Diagnostic Output Failure
4
4
Product Quality Problem
4
4
No Device Output
4
4
Leak/Splash
4
4
Device Contamination with Chemical or Other Material
3
3
Contamination /Decontamination Problem
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Temperature Problem
2
2
Fluid Leak
2
2
Device Displays Incorrect Message
2
2
High Test Results
2
2
Low Test Results
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Defective Device
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Gas Output Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Break
1
1
Component Incompatible
1
1
Melted
1
1
Energy Output Problem
1
1
Overheating of Device
1
1
Peeled/Delaminated
1
1
Packaging Problem
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Ingredient or Reagent Problem
1
5
Ambient Temperature Problem
1
1
Difficult to Open or Close
1
1
Unintended Electrical Shock
1
1
Appropriate Term/Code Not Available
1
1
Missing Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8605
8617
No Consequences Or Impact To Patient
1453
1453
Anxiety
1320
1320
Unspecified Respiratory Problem
1119
1119
Insufficient Information
673
674
No Known Impact Or Consequence To Patient
240
240
Respiratory Tract Infection
201
201
Test Result
78
78
No Information
38
38
Viral Infection
22
22
Headache
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Misdiagnosis
13
13
Burning Sensation
10
10
Fever
8
8
Pain
7
7
Cough
7
7
No Patient Involvement
6
6
Fatigue
6
6
Hypersensitivity/Allergic reaction
5
5
Virus
5
5
Sore Throat
5
5
Epistaxis
4
4
Taste Disorder
4
4
Tinnitus
4
4
Malaise
4
4
Dyspnea
4
4
Vomiting
3
3
No Code Available
3
3
Numbness
2
2
Skin Inflammation/ Irritation
2
2
Blurred Vision
2
2
Pneumonia
2
2
Dizziness
2
2
Distress
2
2
Discomfort
2
2
Emotional Changes
2
2
Diarrhea
2
2
Apnea
2
2
Nausea
2
2
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Intraocular Pressure Increased
1
1
Itching Sensation
1
1
Muscle Weakness
1
1
Bronchitis
1
1
Chest Pain
1
1
Death
1
1
Dehydration
1
1
Chills
1
1
Urinary Tract Infection
1
1
Vertigo
1
1
Visual Impairment
1
1
Alteration in Body Temperature
1
1
Swelling/ Edema
1
1
Eye Pain
1
1
Spontaneous Abortion
1
1
Increased Sensitivity
1
1
Loss of consciousness
1
1
Foreign Body In Patient
1
1
Sensitivity of Teeth
1
1
Neck Pain
1
1
Low Oxygen Saturation
1
1
Paresthesia
1
1
Swollen Lymph Nodes/Glands
1
1
Wheezing
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Molecular, Inc.
I
Oct-14-2021
2
Becton Dickinson & Co.
II
Apr-13-2021
3
Becton Dickinson & Co.
II
Feb-05-2021
4
Becton Dickinson & Co.
II
Aug-04-2020
5
Biomeme, Inc.
II
Jan-04-2022
6
Biomeme, Inc.
III
Feb-01-2021
7
Biomeme, Inc.
II
Dec-01-2020
8
DNA Genotek Inc.
II
Apr-21-2022
9
DiaSorin Molecular LLC
II
Oct-21-2021
10
Life Technologies Corporation
II
Sep-17-2020
11
MESA BIOTECH, INC
I
May-06-2022
12
Meridian Bioscience Inc
II
May-07-2021
13
NeuMoDx Molecular Inc
II
Apr-22-2022
14
NeuMoDx Molecular Inc
II
Mar-08-2022
15
NeuMoDx Molecular Inc
II
Jun-29-2021
16
OPTI Medical Systems, Inc
II
Aug-17-2021
17
Quidel Corporation
II
Sep-15-2021
18
Quidel Corporation
I
Jun-26-2021
19
Roche Molecular Systems, Inc.
II
Apr-13-2021
20
VISBY MEDICAL INC
II
Jan-12-2021
-
-