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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 3478 3478
2024 464 464

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13550 13554
No Apparent Adverse Event 9072 9072
False Negative Result 5317 5326
Incorrect, Inadequate or Imprecise Result or Readings 2341 2341
Erratic Results 492 492
Non Reproducible Results 449 449
Unable to Obtain Readings 333 333
Use of Device Problem 231 231
Insufficient Information 111 111
Improper or Incorrect Procedure or Method 105 105
No Device Output 102 102
Product Quality Problem 72 72
Adverse Event Without Identified Device or Use Problem 59 59
Device Markings/Labelling 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
Output Problem 27 27
Expiration Date Error 21 21
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
Device Ingredient or Reagent Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Patient Device Interaction Problem 8 8
Missing Information 6 6
Obstruction of Flow 6 6
Computer System Security Problem 6 6
Fluid/Blood Leak 6 6
Contamination 5 5
Incomplete or Missing Packaging 5 5
Unexpected Therapeutic Results 5 5
Contamination of Device Ingredient or Reagent 4 4
Detachment of Device or Device Component 4 4
Material Integrity Problem 4 4
Material Discolored 4 4
Crack 3 3
Break 3 3
Material Separation 3 3
Poor Quality Image 3 3
Device Difficult to Setup or Prepare 3 3
Operating System Becomes Nonfunctional 3 3
Packaging Problem 3 3
Contamination /Decontamination Problem 3 3
Unclear Information 3 3
Missing Test Results 3 3
Device Handling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination with Chemical or Other Material 2 2
Unsealed Device Packaging 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
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
Off-Label Use 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
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
Inadequate User Interface 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
No Flow 1 1
Fumes or Vapors 1 1
Failure to Obtain Sample 1 1
Connection Problem 1 1
Unraveled Material 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1
Biocompatibility 1 1
Lack of Effect 1 1
Material Too Soft/Flexible 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Inaccurate Information 1 1
Activation Failure 1 1
Wireless Communication Problem 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22283 22283
Insufficient Information 3175 3188
No Consequences Or Impact To Patient 1415 1415
Viral Infection 133 133
Anxiety 126 126
No Information 76 76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 68 68
Burning Sensation 50 50
Eye Pain 25 25
Headache 22 22
Red Eye(s) 20 20
Test Result 17 17
Pain 16 16
Hypersensitivity/Allergic reaction 14 14
Cough 12 12
No Patient Involvement 11 11
Fever 11 11
Blurred Vision 11 11
Sore Throat 11 11
Unspecified Eye / Vision Problem 10 10
Unspecified Respiratory Problem 10 10
Skin Inflammation/ Irritation 9 9
Malaise 9 9
Dyspnea 9 9
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
Taste Disorder 5 5
Chemical Exposure 5 5
Numbness 4 4
Tachycardia 4 4
Sneezing 4 4
Diarrhea 4 4
Pneumonia 4 4
Nausea 3 3
Distress 3 3
Choking 3 3
Foreign Body In Patient 3 3
Skin Burning Sensation 3 3
Nasal Obstruction 2 2
Decreased Peak Expiratory Flow rate 2 2
Dizziness 2 2
Arthralgia 2 2
Urinary Frequency 2 2
Virus 2 2
Fatigue 2 2
High Blood Pressure/ Hypertension 2 2
Dysphagia/ Odynophagia 2 2
Conjunctivitis 2 2
Arrhythmia 2 2
Bacterial Infection 2 2
Hemorrhage/Bleeding 2 2
Foreign Body Sensation in Eye 1 1
Erythema 1 1
Eye Injury 1 1
Burn(s) 1 1
Cellulitis 1 1
Asthma 1 1
Abdominal Pain 1 1
Hypothermia 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Sepsis 1 1
Rash 1 1
Local Reaction 1 1
Chills 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Depression 1 1
Meningitis 1 1
Reaction 1 1
Weight Changes 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1
Lethargy 1 1
Localized Skin Lesion 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
Decreased Sensitivity 1 1
Convulsion/Seizure 1 1
Contact Dermatitis 1 1
Nodule 1 1
Unspecified Tissue Injury 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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