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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 932 932

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 13687 13691
No Apparent Adverse Event 9234 9234
False Negative Result 5477 5486
Incorrect, Inadequate or Imprecise Result or Readings 2343 2343
Erratic Results 498 498
Non Reproducible Results 461 461
Unable to Obtain Readings 411 411
Use of Device Problem 231 231
Insufficient Information 124 124
Improper or Incorrect Procedure or Method 117 117
No Device Output 102 102
Product Quality Problem 73 73
Adverse Event Without Identified Device or Use Problem 60 60
Device Markings/Labelling Problem 58 58
Component Missing 53 53
Defective Device 39 39
Nonstandard Device 36 36
Manufacturing, Packaging or Shipping Problem 32 32
Appropriate Term/Code Not Available 32 32
Output Problem 29 29
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
Patient Device Interaction Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Ingredient or Reagent Problem 8 8
Obstruction of Flow 6 6
Computer System Security Problem 6 6
Fluid/Blood Leak 6 6
Missing Information 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
Unraveled Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22584 22584
Insufficient Information 3318 3331
No Consequences Or Impact To Patient 1415 1415
Viral Infection 142 142
Anxiety 127 127
No Information 76 76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Burning Sensation 53 53
Headache 27 27
Eye Pain 26 26
Hypersensitivity/Allergic reaction 21 21
Sore Throat 20 20
Red Eye(s) 20 20
Test Result 17 17
Pain 17 17
Fever 16 16
Unspecified Respiratory Problem 15 15
Cough 13 13
No Patient Involvement 11 11
Blurred Vision 11 11
Unspecified Eye / Vision Problem 10 10
Malaise 10 10
Dyspnea 9 9
Skin Inflammation/ Irritation 9 9
Epistaxis 8 8
Eye Burn 7 7
Vomiting 6 6
Swelling/ Edema 6 6
Emotional Changes 6 6
Taste Disorder 5 5
Chemical Exposure 5 5
Numbness 5 5
No Known Impact Or Consequence To Patient 5 5
Pneumonia 4 4
Tachycardia 4 4
Sneezing 4 4
Diarrhea 4 4
Choking 3 3
Nausea 3 3
Distress 3 3
Skin Burning Sensation 3 3
Foreign Body In Patient 3 3
Dysphagia/ Odynophagia 2 2
Nasal Obstruction 2 2
Bacterial Infection 2 2
Hemorrhage/Bleeding 2 2
Depression 2 2
Urinary Frequency 2 2
Unspecified Reproductive System or Breast Problem 2 2
Conjunctivitis 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 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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