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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
2020 1372 1372
2021 6560 6560
2022 13075 13088
2023 3145 3145

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13317 13321
No Apparent Adverse Event 8852 8852
False Negative Result 5062 5071
Incorrect, Inadequate or Imprecise Result or Readings 2339 2339
Erratic Results 489 489
Non Reproducible Results 408 408
Unable to Obtain Readings 257 257
Use of Device Problem 230 230
No Device Output 102 102
Insufficient Information 92 92
Improper or Incorrect Procedure or Method 75 75
Product Quality Problem 72 72
Device Markings/Labelling Problem 57 57
Adverse Event Without Identified Device or Use Problem 57 57
Component Missing 53 53
Defective Device 39 39
Nonstandard Device 35 35
Manufacturing, Packaging or Shipping Problem 32 32
Appropriate Term/Code Not Available 32 32
Expiration Date Error 21 21
Output Problem 20 20
Patient-Device Incompatibility 16 16
Defective Component 15 15
Leak/Splash 14 14
Labelling, Instructions for Use or Training Problem 13 13
Incorrect Measurement 12 12
Inadequate Instructions for Non-Healthcare Professional 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Ingredient or Reagent Problem 8 8
Patient Device Interaction Problem 8 8
Missing Information 6 6
Computer System Security Problem 6 6
Obstruction of Flow 6 6
Unexpected Therapeutic Results 5 5
Incomplete or Missing Packaging 5 5
Fluid/Blood Leak 5 5
Contamination 5 5
Material Discolored 4 4
Contamination of Device Ingredient or Reagent 4 4
Material Integrity Problem 4 4
Operating System Becomes Nonfunctional 3 3
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Contamination /Decontamination Problem 3 3
Crack 3 3
Break 3 3
Material Separation 3 3
Device Difficult to Setup or Prepare 3 3
Unclear Information 3 3
Missing Test Results 3 3
Device Contaminated During Manufacture or Shipping 2 2
Device Handling Problem 2 2
Unsealed Device Packaging 2 2
Poor Quality Image 2 2
Shipping Damage or Problem 2 2
Display or Visual Feedback Problem 2 2
Delivered as Unsterile Product 2 2
Device Emits Odor 2 2
Device Contamination with Chemical or Other Material 2 2
Improper Chemical Reaction 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
No Flow 1 1
Inadequate User Interface 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Connection Problem 1 1
Fumes or Vapors 1 1
Failure to Obtain Sample 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1
Biocompatibility 1 1
Mechanical Problem 1 1
Fire 1 1
Entrapment of Device 1 1
Display Difficult to Read 1 1
Short Fill 1 1
Microbial Contamination of Device 1 1
Difficult to Remove 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Activation Failure 1 1
Wireless Communication Problem 1 1
Patient Data Problem 1 1
Lack of Effect 1 1
Material Too Soft/Flexible 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21667 21667
Insufficient Information 3018 3031
No Consequences Or Impact To Patient 1415 1415
Anxiety 126 126
Viral Infection 121 121
No Information 76 76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 68 68
Burning Sensation 46 46
Eye Pain 22 22
Headache 20 20
Red Eye(s) 18 18
Test Result 17 17
Pain 16 16
Hypersensitivity/Allergic reaction 14 14
Cough 12 12
Blurred Vision 11 11
No Patient Involvement 11 11
Sore Throat 10 10
Fever 10 10
Unspecified Eye / Vision Problem 10 10
Unspecified Respiratory Problem 10 10
Skin Inflammation/ Irritation 9 9
Dyspnea 9 9
Malaise 8 8
Epistaxis 8 8
Eye Burn 7 7
Vomiting 6 6
Emotional Changes 6 6
Swelling/ Edema 6 6
No Known Impact Or Consequence To Patient 5 5
Chemical Exposure 5 5
Numbness 4 4
Sneezing 4 4
Diarrhea 4 4
Pneumonia 4 4
Tachycardia 4 4
Taste Disorder 4 4
Distress 3 3
Choking 3 3
Nasal Obstruction 2 2
Decreased Peak Expiratory Flow rate 2 2
Arthralgia 2 2
Urinary Frequency 2 2
Nausea 2 2
Virus 2 2
High Blood Pressure/ Hypertension 2 2
Dysphagia/ Odynophagia 2 2
Conjunctivitis 2 2
Fatigue 2 2
Hemorrhage/Bleeding 2 2
Arrhythmia 2 2
Bacterial Infection 2 2
Foreign Body In Patient 2 2
Skin Burning Sensation 2 2
Localized Skin Lesion 1 1
Convulsion/Seizure 1 1
Contact Dermatitis 1 1
Nodule 1 1
Unspecified Tissue Injury 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Unspecified Reproductive System or Breast Problem 1 1
Blister 1 1
Burn(s) 1 1
Cellulitis 1 1
Asthma 1 1
Erythema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Hypothermia 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Urinary Tract Infection 1 1
Sepsis 1 1
Rash 1 1
Local Reaction 1 1
Visual Impairment 1 1
Chills 1 1
Dizziness 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Depression 1 1
Meningitis 1 1
Reaction 1 1
Weight Changes 1 1
Decreased Sensitivity 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1
Lethargy 1 1

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 INNOVA MEDICAL GROUP, INC. I Jun-10-2021
15 Jiangsu Well Biotech Co.,Ltd. I Oct-08-2022
16 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
17 LUMINOSTICS, INC dba CLIP HEALTH II Oct-12-2022
18 LumiraDx III Oct-26-2022
19 LumiraDx II Mar-26-2021
20 LumiraDx II Feb-17-2021
21 Lusys Laboratories, Inc. I Mar-10-2022
22 Migo Trading LLC II Dec-27-2021
23 North American Diagnostics I Jul-29-2022
24 Ortho-Clinical Diagnostics, INc. II May-27-2021
25 Ortho-Clinical Diagnostics, Inc. II Mar-17-2021
26 Qiagen Sciences LLC II Feb-01-2021
27 Quidel Corporation II Oct-19-2020
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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