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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 6557 6557
2022 10236 10249

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 10437 10441
No Apparent Adverse Event 6351 6351
False Negative Result 3255 3264
Incorrect, Inadequate or Imprecise Resultor Readings 2223 2223
Non Reproducible Results 302 302
Erratic Results 231 231
Use of Device Problem 184 184
Adverse Event Without Identified Device or Use Problem 48 48
Insufficient Information 38 38
Component Missing 35 35
Product Quality Problem 33 33
Appropriate Term/Code Not Available 32 32
Device Markings/Labelling Problem 30 30
Nonstandard Device 23 23
Improper or Incorrect Procedure or Method 20 20
Defective Device 16 16
Patient-Device Incompatibility 16 16
Manufacturing, Packaging or Shipping Problem 16 16
Leak/Splash 12 12
Labelling, Instructions for Use or Training Problem 9 9
Expiration Date Error 7 7
Output Problem 7 7
Computer System Security Problem 6 6
Inadequate Instructions for Non-Healthcare Professional 6 6
Defective Component 6 6
Therapeutic or Diagnostic Output Failure 5 5
Patient Device Interaction Problem 5 5
Incomplete or Missing Packaging 4 4
Unexpected Therapeutic Results 3 3
Incorrect Measurement 3 3
Break 3 3
Contamination 3 3
Missing Information 3 3
Contamination of Device Ingredient or Reagent 3 3
Detachment of Device or Device Component 2 2
Device Ingredient or Reagent Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 2 2
Operating System Becomes Nonfunctional 2 2
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Crack 2 2
Material Discolored 2 2
Display or Visual Feedback Problem 2 2
Fluid Leak 2 2
Shipping Damage or Problem 2 2
Unable to Obtain Readings 2 2
Device Emits Odor 2 2
Off-Label Use 1 1
Difficult to Remove 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Entrapment of Device 1 1
Fire 1 1
Display Difficult to Read 1 1
Protective Measures Problem 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Patient Data Problem 1 1
Missing Test Results 1 1
Material Too Soft/Flexible 1 1
Inaccurate Information 1 1
Improper Chemical Reaction 1 1
Inadequate User Interface 1 1
Difficult to Open or Remove Packaging Material 1 1
Connection Problem 1 1
Failure to Obtain Sample 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16809 16809
Insufficient Information 1793 1806
No Consequences Or Impact To Patient 1415 1415
Anxiety 126 126
No Information 76 76
Viral Infection 66 66
Burning Sensation 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Headache 17 17
Test Result 17 17
Eye Pain 12 12
Hypersensitivity/Allergic reaction 12 12
Pain 11 11
No Patient Involvement 11 11
Blurred Vision 9 9
Red Eye(s) 8 8
Sore Throat 8 8
Eye Burn 7 7
Epistaxis 7 7
Skin Inflammation/ Irritation 7 7
Unspecified Eye / Vision Problem 6 6
Cough 6 6
Emotional Changes 6 6
Fever 6 6
No Known Impact Or Consequence To Patient 5 5
Swelling/ Edema 5 5
Numbness 4 4
Pneumonia 4 4
Vomiting 3 3
Taste Disorder 3 3
Unspecified Respiratory Problem 3 3
Nasal Obstruction 2 2
Chemical Exposure 2 2
Dizziness 2 2
Urinary Frequency 2 2
Distress 2 2
Arthralgia 2 2
Fatigue 2 2
Virus 2 2
Hemorrhage/Bleeding 2 2
Diarrhea 2 2
High Blood Pressure/ Hypertension 2 2
Hypothermia 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Nausea 1 1
Dyspnea 1 1
Asthma 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Foreign Body Sensation in Eye 1 1
Eye Injury 1 1
Sepsis 1 1
Urinary Tract Infection 1 1
Rash 1 1
Local Reaction 1 1
Chills 1 1
Sneezing 1 1
Malaise 1 1
Depression 1 1
Meningitis 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1
Lethargy 1 1
Weight Changes 1 1
Foreign Body In Patient 1 1
Convulsion/Seizure 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 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 E25Bio, Inc. I Feb-09-2022
11 ELLUME LTD I Nov-10-2021
12 Empowered Diagnostics LLC I Jan-29-2022
13 INNOVA MEDICAL GROUP, INC. I Jun-10-2021
14 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
15 LumiraDx II Mar-26-2021
16 LumiraDx II Feb-17-2021
17 Lusys Laboratories, Inc. I Mar-10-2022
18 Migo Trading LLC II Dec-27-2021
19 North American Diagnostics I Jul-29-2022
20 Ortho-Clinical Diagnostics, INc. II May-27-2021
21 Ortho-Clinical Diagnostics, Inc. II Mar-17-2021
22 Qiagen Sciences LLC II Feb-01-2021
23 Quidel Corporation II Oct-19-2020
24 SD Biosensor, Inc. I Mar-16-2022
25 SML Distribution, LLC I May-03-2022
26 Siemens Healthcare Diagnostics, Inc II Nov-03-2021
27 USA Medical, LLC II May-06-2022
28 Versea Diagnostics LLC II Sep-03-2021
29 WHPM Inc. II Apr-07-2022
30 Woodside Acquisitions Inc. I May-12-2022
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