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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 6561 6561
2022 13082 13095

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 11864 11868
No Apparent Adverse Event 7545 7545
False Negative Result 4301 4310
Incorrect, Inadequate or Imprecise Result or Readings 2280 2280
Erratic Results 346 346
Non Reproducible Results 345 345
Use of Device Problem 220 220
Product Quality Problem 60 60
Insufficient Information 57 57
Adverse Event Without Identified Device or Use Problem 52 52
Component Missing 46 46
Device Markings/Labelling Problem 38 38
Appropriate Term/Code Not Available 32 32
Improper or Incorrect Procedure or Method 26 26
Nonstandard Device 24 24
Defective Device 22 22
Manufacturing, Packaging or Shipping Problem 21 21
Output Problem 20 20
Patient-Device Incompatibility 16 16
Defective Component 14 14
Leak/Splash 13 13
Expiration Date Error 12 12
Labelling, Instructions for Use or Training Problem 10 10
Unable to Obtain Readings 7 7
Inadequate Instructions for Non-Healthcare Professional 7 7
Therapeutic or Diagnostic Output Failure 7 7
Patient Device Interaction Problem 6 6
Computer System Security Problem 6 6
Missing Information 6 6
Unexpected Therapeutic Results 5 5
Incorrect Measurement 5 5
Fluid/Blood Leak 4 4
Incomplete or Missing Packaging 4 4
No Device Output 4 4
Unsealed Device Packaging 3 3
Obstruction of Flow 3 3
Break 3 3
Contamination 3 3
Material Discolored 3 3
Contamination of Device Ingredient or Reagent 3 3
Detachment of Device or Device Component 3 3
Device Ingredient or Reagent Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Packaging Problem 2 2
Operating System Becomes Nonfunctional 2 2
Material Integrity Problem 2 2
Contamination /Decontamination Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Crack 2 2
Display or Visual Feedback Problem 2 2
Poor Quality Image 2 2
Device Emits Odor 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Missing Test Results 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Inaccurate Information 1 1
Lack of Effect 1 1
Short Fill 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Delivered as Unsterile Product 1 1
Mechanical Problem 1 1
Entrapment of Device 1 1
Fire 1 1
Display Difficult to Read 1 1
No Flow 1 1
Protective Measures Problem 1 1
Material Too Soft/Flexible 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Improper Chemical Reaction 1 1
Inadequate User Interface 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19463 19463
Insufficient Information 2071 2084
No Consequences Or Impact To Patient 1415 1415
Anxiety 126 126
Viral Infection 84 84
No Information 76 76
Burning Sensation 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Headache 21 21
Eye Pain 18 18
Test Result 17 17
Red Eye(s) 16 16
Pain 16 16
Hypersensitivity/Allergic reaction 13 13
Blurred Vision 11 11
No Patient Involvement 11 11
Fever 10 10
Sore Throat 8 8
Eye Burn 7 7
Cough 7 7
Epistaxis 7 7
Skin Inflammation/ Irritation 7 7
Swelling/ Edema 6 6
Unspecified Eye / Vision Problem 6 6
Emotional Changes 6 6
Unspecified Respiratory Problem 5 5
No Known Impact Or Consequence To Patient 5 5
Numbness 4 4
Diarrhea 4 4
Pneumonia 4 4
Vomiting 3 3
Chemical Exposure 3 3
Taste Disorder 3 3
Nasal Obstruction 2 2
Foreign Body In Patient 2 2
Dizziness 2 2
Urinary Frequency 2 2
Distress 2 2
Arthralgia 2 2
Malaise 2 2
Fatigue 2 2
Virus 2 2
Hemorrhage/Bleeding 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
Erythema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Sepsis 1 1
Urinary Tract Infection 1 1
Rash 1 1
Local Reaction 1 1
Chills 1 1
Sneezing 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
Convulsion/Seizure 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Blister 1 1
Skin Burning Sensation 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 Mar-16-2022
29 SML Distribution, LLC I May-03-2022
30 Siemens Healthcare Diagnostics, Inc II Nov-03-2021
31 USA Medical, LLC II May-06-2022
32 Universal Meditech Inc. I Jan-27-2023
33 Versea Diagnostics LLC II Sep-03-2021
34 WHPM Inc. II Apr-07-2022
35 Woodside Acquisitions Inc. I May-12-2022
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