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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 1637 1667
2021 7300 7383
2022 7022 7061
2023 3190 3194
2024 610 613
2025 371 371

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13398 13489
Incorrect, Inadequate or Imprecise Result or Readings 3503 3538
False Negative Result 2808 2826
Output Problem 2610 2610
Non Reproducible Results 2270 2270
No Apparent Adverse Event 1396 1397
Erratic Results 580 581
Nonstandard Device 109 109
Unable to Obtain Readings 103 103
Off-Label Use 68 68
Device Contaminated at the User Facility 51 51
Improper or Incorrect Procedure or Method 38 38
Adverse Event Without Identified Device or Use Problem 32 33
Use of Device Problem 27 27
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 19
Application Program Problem 9 9
Product Quality Problem 9 23
Contamination 8 8
Leak/Splash 7 7
Optical Obstruction 6 6
Patient-Device Incompatibility 6 7
Patient Device Interaction Problem 6 6
Contamination /Decontamination Problem 5 6
No Device Output 4 4
Device Displays Incorrect Message 4 5
Manufacturing, Packaging or Shipping Problem 4 4
Therapeutic or Diagnostic Output Failure 4 5
High Test Results 4 4
Unexpected Therapeutic Results 3 3
Failure to Calibrate 3 3
Missing Information 3 3
Device Contamination with Chemical or Other Material 3 5
Material Separation 3 5
Signal Artifact/Noise 3 3
Component Missing 2 2
Environmental Particulates 2 2
Erratic or Intermittent Display 2 2
Break 2 4
Inadequate Instructions for Non-Healthcare Professional 2 2
Fluid/Blood Leak 2 2
Temperature Problem 2 2
Lack of Effect 1 1
Structural Problem 1 3
Microbial Contamination of Device 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16549 16597
Insufficient Information 1480 1553
No Consequences Or Impact To Patient 1453 1455
Anxiety 1324 1324
Unspecified Respiratory Problem 1125 1125
Viral Infection 362 369
No Known Impact Or Consequence To Patient 240 246
Respiratory Tract Infection 210 210
Test Result 79 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Sore Throat 61 63
Fever 48 50
Cough 47 50
Headache 44 47
No Information 38 38
Fatigue 32 38
Pain 17 22
Dyspnea 13 15
Misdiagnosis 13 13
Burning Sensation 11 12
Malaise 9 9
Hypersensitivity/Allergic reaction 6 6
Taste Disorder 6 9
No Patient Involvement 6 6
Virus 5 5
Chills 5 6
Pneumonia 4 4
Tinnitus 4 6
Nausea 4 7
Alteration in Body Temperature 4 4
Epistaxis 4 4
Tachycardia 3 3
Discomfort 3 3
Vomiting 3 7
Diarrhea 3 5
Muscle Weakness 3 5
No Code Available 3 3
Sneezing 3 3
Chest Pain 2 4
Distress 2 2
Myalgia 2 2
Numbness 2 3
Itching Sensation 2 2
Skin Inflammation/ Irritation 2 2
Dizziness 2 3
Emotional Changes 2 2
Apnea 2 2
Hemorrhage/Bleeding 2 2
Blurred Vision 2 2
Sleep Dysfunction 2 2

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