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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronavirus antigen detection test system.
Definition The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Product CodeQKP
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 6561 6677
2022 13075 13502
2023 3478 3518
2024 1406 1406
2025 755 755

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 14156 14307
No Apparent Adverse Event 9967 9968
False Negative Result 5649 5697
Incorrect, Inadequate or Imprecise Result or Readings 1087 1221
Unable to Obtain Readings 592 592
Erratic Results 507 507
Non Reproducible Results 461 466
Use of Device Problem 229 229
Improper or Incorrect Procedure or Method 127 127
Insufficient Information 126 126
No Device Output 102 102
Product Quality Problem 76 163
Adverse Event Without Identified Device or Use Problem 62 89
Device Markings/Labelling Problem 61 85
Component Missing 53 88
Defective Device 39 69
Nonstandard Device 36 84
Appropriate Term/Code Not Available 32 32
Manufacturing, Packaging or Shipping Problem 32 59
Output Problem 29 41
Expiration Date Error 24 38
Patient-Device Incompatibility 16 20
Leak/Splash 14 14
Defective Component 14 33
Labelling, Instructions for Use or Training Problem 13 16
Incorrect Measurement 12 12
Inadequate Instructions for Non-Healthcare Professional 9 9
Patient Device Interaction Problem 9 10
Device Ingredient or Reagent Problem 8 8
Therapeutic or Diagnostic Output Failure 8 12
Fluid/Blood Leak 6 6
Obstruction of Flow 6 6
Computer System Security Problem 6 6
Missing Information 6 7
Incomplete or Missing Packaging 5 8
Unexpected Therapeutic Results 5 5
Contamination 5 5
Material Discolored 4 4
Material Integrity Problem 4 5
Contamination of Device Ingredient or Reagent 4 4
Detachment of Device or Device Component 4 5
Device Emits Odor 3 3
Contamination /Decontamination Problem 3 5
Material Separation 3 3
Packaging Problem 3 4
Unraveled Material 3 3
Unclear Information 3 3
Device Difficult to Setup or Prepare 3 6
Poor Quality Image 3 3
Break 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22339 22619
Insufficient Information 3738 3959
No Consequences Or Impact To Patient 280 280
Viral Infection 162 189
Anxiety 127 128
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 72 87
Burning Sensation 58 78
Eye Pain 28 28
Headache 26 50
Red Eye(s) 24 24
Hypersensitivity/Allergic reaction 21 21
Sore Throat 20 24
Fever 17 17
Pain 16 26
Unspecified Respiratory Problem 15 17
Blurred Vision 13 13
Cough 12 14
Malaise 11 13
Dyspnea 10 11
Unspecified Eye / Vision Problem 10 10
Skin Inflammation/ Irritation 9 13
Epistaxis 9 9
Eye Burn 7 7
Swelling/ Edema 6 6
Emotional Changes 6 11
Numbness 5 10
Vomiting 5 5
Taste Disorder 5 5
Chemical Exposure 5 5
Tachycardia 4 4
Diarrhea 4 5
Fatigue 4 4
Sneezing 4 4
Test Result 4 4
Skin Burning Sensation 3 3
Distress 3 3
Pneumonia 3 4
Choking 3 3
Nausea 3 4
Foreign Body In Patient 3 3
Decreased Sensitivity 2 2
Dysphagia/ Odynophagia 2 2
Arthralgia 2 2
Nasal Obstruction 2 2
Arrhythmia 2 2
Dizziness 2 2
No Patient Involvement 2 2
Depression 2 2
No Information 2 2
Bacterial Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acon Biotech (Hangzhou) Co., Ltd. II Apr-15-2022
2 Beckman Coulter Inc. II Aug-12-2021
3 Beckman Coulter Inc. II May-21-2021
4 CELLTRION USA INC I Apr-27-2022
5 CELLTRION USA INC II Mar-08-2022
6 CELLTRION USA INC I Mar-02-2022
7 CELLTRION USA INC I Mar-02-2022
8 CELLTRION USA INC II Feb-03-2022
9 Cellex II Sep-13-2021
10 Detect Headquarters II Jan-04-2023
11 E25Bio, Inc. I Feb-09-2022
12 ELLUME LTD I Nov-10-2021
13 Empowered Diagnostics LLC I Jan-29-2022
14 Guangzhou Pluslife Biotech Co., Ltd. II Jun-13-2025
15 INNOVA MEDICAL GROUP, INC. I Jun-10-2021
16 Jiangsu Well Biotech Co.,Ltd. I Oct-08-2022
17 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
18 LUMINOSTICS, INC dba CLIP HEALTH II Oct-12-2022
19 LumiraDx III Oct-26-2022
20 LumiraDx II Mar-26-2021
21 LumiraDx II Feb-17-2021
22 Lusys Laboratories, Inc. I Mar-10-2022
23 Migo Trading LLC II Dec-27-2021
24 North American Diagnostics I Jul-29-2022
25 Ortho-Clinical Diagnostics, INc. II May-27-2021
26 Ortho-Clinical Diagnostics, Inc. II Mar-17-2021
27 Qiagen Sciences LLC II Feb-01-2021
28 SD Biosensor, Inc. I May-23-2023
29 SD Biosensor, Inc. I Mar-16-2022
30 SML Distribution, LLC I May-03-2022
31 Siemens Healthcare Diagnostics, Inc II Nov-03-2021
32 USA Medical, LLC II May-06-2022
33 Universal Meditech Inc. I Jan-27-2023
34 Versea Diagnostics LLC II Sep-03-2021
35 WHPM Inc. II Apr-07-2022
36 Woodside Acquisitions Inc. I May-12-2022
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