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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeQJR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 1636 1637
2021 7298 7306
2022 7022 7026
2023 3190 3190
2024 442 442

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13007 13015
Incorrect, Inadequate or Imprecise Result or Readings 3494 3494
False Negative Result 2738 2738
Output Problem 2607 2607
Non Reproducible Results 2264 2264
No Apparent Adverse Event 1384 1385
Erratic Results 543 543
Nonstandard Device 109 109
Unable to Obtain Readings 73 73
Off-Label Use 68 68
Device Contaminated at the User Facility 51 51
Improper or Incorrect Procedure or Method 37 37
Adverse Event Without Identified Device or Use Problem 32 32
Use of Device Problem 26 26
Increased Sensitivity 25 25
Insufficient Information 21 21
Defective Component 14 14
Low Readings 13 13
Incorrect Measurement 12 12
Device Markings/Labelling Problem 10 10
Application Program Problem 9 9
Contamination 8 8
Leak/Splash 7 7
Product Quality Problem 7 7
Patient-Device Incompatibility 6 6
Optical Obstruction 6 6
Patient Device Interaction Problem 5 5
Contamination /Decontamination Problem 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
High Test Results 4 4
No Device Output 4 4
Failure to Calibrate 3 3
Unexpected Therapeutic Results 3 3
Material Separation 3 3
Missing Information 3 3
Device Displays Incorrect Message 3 3
Device Contamination with Chemical or Other Material 3 3
Temperature Problem 2 2
Component Missing 2 2
Break 2 2
Fluid/Blood Leak 2 2
Gas Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Component Incompatible 1 1
Erratic or Intermittent Display 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Melted 1 1
Device Contamination with Body Fluid 1 1
Microbial Contamination of Device 1 1
Low Test Results 1 1
Inadequacy of Device Shape and/or Size 1 1
Energy Output Problem 1 1
Unintended Electrical Shock 1 1
Appropriate Term/Code Not Available 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Ambient Temperature Problem 1 1
Difficult to Open or Close 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Ingredient or Reagent Problem 1 5
Structural Problem 1 1
Expiration Date Error 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16026 16038
Insufficient Information 1468 1469
No Consequences Or Impact To Patient 1453 1453
Anxiety 1322 1322
Unspecified Respiratory Problem 1123 1123
Viral Infection 362 362
No Known Impact Or Consequence To Patient 240 240
Respiratory Tract Infection 210 210
Test Result 78 78
Sore Throat 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Fever 48 48
Cough 45 45
Headache 44 44
No Information 38 38
Fatigue 31 31
Pain 17 17
Misdiagnosis 13 13
Dyspnea 13 13
Burning Sensation 11 11
Malaise 9 9
No Patient Involvement 6 6
Taste Disorder 6 6
Hypersensitivity/Allergic reaction 6 6
Chills 5 5
Virus 5 5
Tinnitus 4 4
Pneumonia 4 4
Nausea 4 4
Epistaxis 4 4
Alteration in Body Temperature 4 4
Discomfort 3 3
No Code Available 3 3
Tachycardia 3 3
Vomiting 3 3
Sneezing 3 3
Muscle Weakness 3 3
Diarrhea 3 3
Emotional Changes 2 2
Apnea 2 2
Chest Pain 2 2
Itching Sensation 2 2
Myalgia 2 2
Dizziness 2 2
Blurred Vision 2 2
Numbness 2 2
Sleep Dysfunction 2 2
Distress 2 2
Skin Inflammation/ Irritation 2 2
Wheezing 1 1
Decreased Appetite 1 1
Swelling/ Edema 1 1
Swollen Lymph Nodes/Glands 1 1
Foreign Body In Patient 1 1
Eye Pain 1 1
Unspecified Eye / Vision Problem 1 1
Spontaneous Abortion 1 1
Increased Sensitivity 1 1
Depression 1 1
Sensitivity of Teeth 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
Cognitive Changes 1 1
Lethargy 1 1
Loss of consciousness 1 1
Paresthesia 1 1
Visual Impairment 1 1
Urinary Tract Infection 1 1
Vertigo 1 1
Rash 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Inflammation 1 1
Intraocular Pressure Increased 1 1
Death 1 1
Dehydration 1 1
Arrhythmia 1 1
Bronchitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Dec-20-2022
2 Abbott Molecular, Inc. II Sep-06-2022
3 Abbott Molecular, Inc. I Oct-14-2021
4 Becton Dickinson & Co. II Jun-05-2024
5 Becton Dickinson & Co. II Apr-13-2021
6 Becton Dickinson & Co. II Feb-05-2021
7 Becton Dickinson & Co. II Aug-04-2020
8 Biomeme, Inc. II Jan-04-2022
9 Biomeme, Inc. III Feb-01-2021
10 Biomeme, Inc. II Dec-01-2020
11 DNA Genotek Inc. II Apr-21-2022
12 DiaSorin Molecular LLC II Mar-03-2023
13 DiaSorin Molecular LLC II Oct-21-2021
14 GS Biomark LLC II Nov-29-2022
15 Life Technologies Corporation II Sep-17-2020
16 Luminex Corporation II Oct-26-2022
17 Luminex Corporation II Aug-17-2022
18 MESA BIOTECH, INC I May-06-2022
19 Meridian Bioscience Inc II Jan-20-2023
20 Meridian Bioscience Inc II May-07-2021
21 NeuMoDx Molecular Inc III Jul-05-2023
22 NeuMoDx Molecular Inc II Apr-22-2022
23 NeuMoDx Molecular Inc II Mar-08-2022
24 NeuMoDx Molecular Inc II Jun-29-2021
25 OPTI Medical Systems, Inc II Aug-17-2021
26 Qiagen GmbH II Jul-21-2023
27 Quidel Corporation II Sep-15-2021
28 Quidel Corporation I Jun-26-2021
29 Roche Molecular Systems, Inc. II Apr-13-2021
30 VISBY MEDICAL INC II Jan-12-2021
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