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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 1406 1406
2025 497 497

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 14212 14216
No Apparent Adverse Event 9838 9838
False Negative Result 5659 5668
Incorrect, Inadequate or Imprecise Result or Readings 2348 2348
Erratic Results 502 502
Unable to Obtain Readings 494 494
Non Reproducible Results 465 465
Use of Device Problem 231 231
Insufficient Information 129 129
Improper or Incorrect Procedure or Method 128 128
No Device Output 102 102
Product Quality Problem 73 73
Adverse Event Without Identified Device or Use Problem 62 62
Device Markings/Labelling Problem 59 59
Component Missing 53 53
Defective Device 39 39
Nonstandard Device 36 36
Appropriate Term/Code Not Available 32 32
Manufacturing, Packaging or Shipping Problem 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
Patient Device Interaction Problem 9 9
Inadequate Instructions for Non-Healthcare Professional 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Ingredient or Reagent Problem 8 8
Missing Information 6 6
Obstruction of Flow 6 6
Fluid/Blood Leak 6 6
Computer System Security Problem 6 6
Unexpected Therapeutic Results 5 5
Incomplete or Missing Packaging 5 5
Contamination 5 5
Material Integrity Problem 4 4
Detachment of Device or Device Component 4 4
Contamination of Device Ingredient or Reagent 4 4
Material Discolored 4 4
Material Separation 3 3
Unclear Information 3 3
Contamination /Decontamination Problem 3 3
Poor Quality Image 3 3
Device Emits Odor 3 3
Unraveled Material 3 3
Device Difficult to Setup or Prepare 3 3
Missing Test Results 3 3
Break 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23187 23187
Insufficient Information 3659 3672
No Consequences Or Impact To Patient 1415 1415
Viral Infection 160 160
Anxiety 127 127
No Information 76 76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Burning Sensation 58 58
Eye Pain 28 28
Headache 27 27
Red Eye(s) 24 24
Hypersensitivity/Allergic reaction 21 21
Sore Throat 20 20
Fever 18 18
Pain 17 17
Test Result 17 17
Unspecified Respiratory Problem 15 15
Cough 13 13
Blurred Vision 13 13
Malaise 11 11
No Patient Involvement 11 11
Unspecified Eye / Vision Problem 10 10
Dyspnea 10 10
Epistaxis 9 9
Skin Inflammation/ Irritation 9 9
Eye Burn 7 7
Vomiting 6 6
Emotional Changes 6 6
Swelling/ Edema 6 6
Numbness 5 5
Taste Disorder 5 5
No Known Impact Or Consequence To Patient 5 5
Chemical Exposure 5 5
Sneezing 4 4
Tachycardia 4 4
Pneumonia 4 4
Diarrhea 4 4
Nausea 3 3
Foreign Body In Patient 3 3
Skin Burning Sensation 3 3
Choking 3 3
Distress 3 3
Fatigue 3 3
Dysphagia/ Odynophagia 2 2
Itching Sensation 2 2
Conjunctivitis 2 2
Decreased Sensitivity 2 2
Virus 2 2
Unspecified Reproductive System or Breast Problem 2 2
Unspecified Immune System Problem 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 Guangzhou Pluslife Biotech Co., Ltd. II Jun-13-2025
15 INNOVA MEDICAL GROUP, INC. I Jun-10-2021
16 Jiangsu Well Biotech Co.,Ltd. I Oct-08-2022
17 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
18 LUMINOSTICS, INC dba CLIP HEALTH II Oct-12-2022
19 LumiraDx III Oct-26-2022
20 LumiraDx II Mar-26-2021
21 LumiraDx II Feb-17-2021
22 Lusys Laboratories, Inc. I Mar-10-2022
23 Migo Trading LLC II Dec-27-2021
24 North American Diagnostics I Jul-29-2022
25 Ortho-Clinical Diagnostics, INc. II May-27-2021
26 Ortho-Clinical Diagnostics, Inc. II Mar-17-2021
27 Qiagen Sciences LLC II Feb-01-2021
28 Quidel Corporation II Oct-19-2020
29 SD Biosensor, Inc. I May-23-2023
30 SD Biosensor, Inc. I Mar-16-2022
31 SML Distribution, LLC I May-03-2022
32 Siemens Healthcare Diagnostics, Inc II Nov-03-2021
33 USA Medical, LLC II May-06-2022
34 Universal Meditech Inc. I Jan-27-2023
35 Versea Diagnostics LLC II Sep-03-2021
36 WHPM Inc. II Apr-07-2022
37 Woodside Acquisitions Inc. I May-12-2022
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