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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
2021 7300 7383
2022 7022 7061
2023 3190 3194
2024 610 613
2025 370 370
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 12768 12784
False Negative Result 2354 2357
Incorrect, Inadequate or Imprecise Result or Readings 2234 2234
Output Problem 2023 2023
Non Reproducible Results 1702 1702
No Apparent Adverse Event 1387 1387
Imprecise or Erratic Results 580 581
Nonstandard Device 107 107
Unable to Obtain Readings 100 100
Off-Label Use 68 68
Device Contaminated at the User Facility 51 51
Increased Sensitivity 25 25
Use of Device Problem 25 25
Improper or Incorrect Procedure or Method 22 22
Defective Component 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Low Readings 13 13
Incorrect Measurement 12 12
Device Markings/Labelling Problem 9 9
Insufficient Device Problem Information 9 9
Leak/Splash 7 7
Optical Obstruction 6 6
Contamination 6 6
Signal Artifact/Noise 3 3
Failure to Calibrate 3 3
No Device Output 2 2
Erratic or Intermittent Display 2 2
Missing Information 2 2
Environmental Particulates 2 2
Material Separation 2 2
Product Quality Problem 2 2
High Test Results 2 2
Patient Device Interaction Problem 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Lack of Effect 1 1
Microbial Contamination of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Energy Output Problem 1 1
Fracture 1 1
Unintended Electrical Shock 1 1
Mechanical Problem 1 1
Break 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Display or Visual Feedback Problem 1 1
Gas Output Problem 1 1
Device Displays Incorrect Message 1 1
Device Ingredient or Reagent Problem 1 5
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16232 16275
Insufficient Information 1455 1521
Anxiety 1319 1319
Unspecified Respiratory Problem 1120 1120
No Consequences Or Impact To Patient 400 400
Viral Infection 362 369
Respiratory Tract Infection 210 210
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 62 62
Sore Throat 61 63
Cough 47 50
Fever 46 48
Headache 41 44
Fatigue 32 38
Pain 15 20
Dyspnea 12 14
Burning Sensation 10 11
Malaise 8 8
Hypersensitivity/Allergic reaction 6 6
Taste Disorder 6 9
Chills 5 6
Tinnitus 4 6
Nausea 4 7
Alteration in Body Temperature 4 4
Epistaxis 4 4
Muscle Weakness/Atrophy 3 5
Sneezing 3 3
Tachycardia 3 3
Pneumonia 3 3
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
Diarrhea 3 5
Vomiting 3 7
Distress 2 2
Blurred Vision 2 2
Numbness 2 3
Discomfort 2 2
Chest Pain 2 4
Myalgia 2 2
Itching Sensation 2 2
Skin Inflammation/ Irritation 2 2
Test Result 2 2
Dizziness 2 3
Virus 2 2
Emotional Changes 2 2
Apnea 2 2
Sleep Dysfunction 2 2
Foreign Body In Patient 1 1
Neck Pain 1 1
Rash 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II May-12-2025
2 Abbott Molecular, Inc. II Dec-20-2022
3 Abbott Molecular, Inc. II Sep-06-2022
4 Abbott Molecular, Inc. I Oct-14-2021
5 Becton Dickinson & Co. II Jun-05-2024
6 Becton Dickinson & Co. II Apr-13-2021
7 Becton Dickinson & Co. II Feb-05-2021
8 Biomeme, Inc. II Jan-04-2022
9 Biomeme, Inc. III Feb-01-2021
10 DNA Genotek Inc. II Apr-21-2022
11 DiaSorin Molecular LLC II Mar-03-2023
12 DiaSorin Molecular LLC II Oct-21-2021
13 GS Biomark LLC II Nov-29-2022
14 Luminex Corporation II Oct-26-2022
15 Luminex Corporation II Aug-17-2022
16 MESA BIOTECH, INC I May-06-2022
17 Meridian Bioscience Inc II Jan-20-2023
18 Meridian Bioscience Inc II May-07-2021
19 NeuMoDx Molecular Inc III Jul-05-2023
20 NeuMoDx Molecular Inc II Apr-22-2022
21 NeuMoDx Molecular Inc II Mar-08-2022
22 NeuMoDx Molecular Inc II Jun-29-2021
23 OPTI Medical Systems, Inc II Aug-17-2021
24 Qiagen GmbH II Jul-21-2023
25 Quidel Corporation II Sep-15-2021
26 Quidel Corporation I Jun-26-2021
27 Roche Molecular Systems, Inc. II Apr-13-2021
28 VISBY MEDICAL INC II Jan-12-2021
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