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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, coronavirus serological
Definition The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
Product CodeQKO
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 860 863
2021 609 613
2022 71 71
2023 6 9
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 729 730
False Negative Result 563 564
Incorrect, Inadequate or Imprecise Result or Readings 176 179
Low Test Results 31 31
Non Reproducible Results 19 19
Failure to Calibrate 16 16
High Test Results 14 14
Unable to Obtain Readings 11 11
Adverse Event Without Identified Device or Use Problem 10 11
Improper or Incorrect Procedure or Method 5 5
Erratic Results 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Apparent Adverse Event 3 3
Off-Label Use 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Incorrect Measurement 2 2
Product Quality Problem 2 6
Inadequate Instructions for Non-Healthcare Professional 1 4
Output Problem 1 1
Insufficient Information 1 1
High Readings 1 1
Use of Device Problem 1 1
Missing Test Results 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1031 1035
No Known Impact Or Consequence To Patient 297 298
No Consequences Or Impact To Patient 116 116
Insufficient Information 84 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Test Result 7 7
Virus 5 6
No Code Available 4 4
Headache 2 4
Tingling 1 1
Cognitive Changes 1 1
Palpitations 1 1
Needle Stick/Puncture 1 1
Fever 1 3
Numbness 1 1
No Patient Involvement 1 1
Viral Infection 1 1
Reaction 1 1
Cough 1 3
Sore Throat 1 3

Recalls
Manufacturer Recall Class Date Posted
1 AZURE BIOTECH INC II Apr-16-2021
2 Ansh Labs, LLC II Jan-11-2021
3 Beckman Coulter Inc. II Sep-22-2021
4 Beckman Coulter Inc. II Jun-21-2021
5 Beckman Coulter Inc. II Jan-15-2021
6 Chembio Diagnostics, Inc II Aug-14-2020
7 Confirm Biosciences Inc II Feb-16-2021
8 Empowered Diagnostics LLC I Jan-29-2022
9 Epitope Diagnostics, Inc. II Nov-06-2020
10 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
11 LumiraDx II Jul-22-2022
12 Lusys Laboratories, Inc. I Mar-10-2022
13 Ortho Clinical Diagnostics II Aug-07-2020
14 Ortho Clinical Diagnostics Inc II Oct-15-2021
15 Ortho-Clinical Diagnostics, Inc. II Apr-18-2023
16 Ortho-Clinical Diagnostics, Inc. II Jul-12-2022
17 PROTERIXBIO II May-11-2022
18 Sky Medical Supplies and Equipments LLC II Feb-16-2021
19 Thera Test Laboratories, Inc. II Aug-27-2021
20 Thera Test Laboratories, Inc. II Aug-27-2021
21 Universal Meditech Inc. II Oct-23-2023
22 Versea Diagnostics LLC II Sep-03-2021
23 bioMerieux, Inc. II Dec-28-2021
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