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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 613 613
2025 216 216

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13257 13265
Incorrect, Inadequate or Imprecise Result or Readings 3499 3499
False Negative Result 2801 2801
Output Problem 2610 2610
Non Reproducible Results 2268 2268
No Apparent Adverse Event 1396 1397
Erratic Results 580 580
Nonstandard Device 109 109
Unable to Obtain Readings 100 100
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 32
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 10
Application Program Problem 9 9
Product Quality Problem 9 9
Contamination 8 8
Leak/Splash 7 7
Patient-Device Incompatibility 6 6
Patient Device Interaction Problem 6 6
Optical Obstruction 6 6
Contamination /Decontamination Problem 5 5
Device Displays Incorrect Message 4 4
No Device Output 4 4
High Test Results 4 4
Therapeutic or Diagnostic Output Failure 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Separation 3 3
Unexpected Therapeutic Results 3 3
Device Contamination with Chemical or Other Material 3 3
Failure to Calibrate 3 3
Missing Information 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Environmental Particulates 2 2
Temperature Problem 2 2
Fluid/Blood Leak 2 2
Erratic or Intermittent Display 2 2
Break 2 2
Component Missing 2 2
Lack of Maintenance Documentation or Guidelines 1 1
Gas Output Problem 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16405 16417
Insufficient Information 1470 1471
No Consequences Or Impact To Patient 1453 1453
Anxiety 1324 1324
Unspecified Respiratory Problem 1125 1125
Viral Infection 362 362
No Known Impact Or Consequence To Patient 240 240
Respiratory Tract Infection 210 210
Test Result 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Sore Throat 61 61
Fever 48 48
Cough 47 47
Headache 44 44
No Information 38 38
Fatigue 32 32
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
Alteration in Body Temperature 4 4
Epistaxis 4 4
Tinnitus 4 4
Pneumonia 4 4
Nausea 4 4
No Code Available 3 3
Vomiting 3 3
Sneezing 3 3
Tachycardia 3 3
Discomfort 3 3
Muscle Weakness 3 3
Diarrhea 3 3
Apnea 2 2
Skin Inflammation/ Irritation 2 2
Dizziness 2 2
Chest Pain 2 2
Blurred Vision 2 2
Itching Sensation 2 2
Sleep Dysfunction 2 2
Numbness 2 2
Emotional Changes 2 2
Hemorrhage/Bleeding 2 2
Distress 2 2
Myalgia 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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