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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
2021 609 613
2022 71 71
2023 6 9
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 314 315
False Positive Result 285 286
Incorrect, Inadequate or Imprecise Result or Readings 32 34
Low Test Results 26 26
Non Reproducible Results 16 16
Failure to Calibrate 16 16
Unable to Obtain Readings 11 11
Adverse Event Without Identified Device or Use Problem 7 7
High Test Results 4 4
Erratic Results 3 3
Off-Label Use 2 2
Inadequate Instructions for Non-Healthcare Professional 1 4
Insufficient Information 1 1
High Readings 1 1
Product Quality Problem 1 4
Retraction Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 556 560
Insufficient Information 64 65
No Known Impact Or Consequence To Patient 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
No Consequences Or Impact To Patient 17 17
Cognitive Changes 1 1
Needle Stick/Puncture 1 1
Fever 1 3
Viral Infection 1 1
Reaction 1 1
Cough 1 3
Headache 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 Confirm Biosciences Inc II Feb-16-2021
7 Empowered Diagnostics LLC I Jan-29-2022
8 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD I May-28-2021
9 LumiraDx II Jul-22-2022
10 Lusys Laboratories, Inc. I Mar-10-2022
11 Ortho Clinical Diagnostics Inc II Oct-15-2021
12 Ortho-Clinical Diagnostics, Inc. II Apr-18-2023
13 Ortho-Clinical Diagnostics, Inc. II Jul-12-2022
14 PROTERIXBIO II May-11-2022
15 Sky Medical Supplies and Equipments LLC II Feb-16-2021
16 Thera Test Laboratories, Inc. II Aug-27-2021
17 Thera Test Laboratories, Inc. II Aug-27-2021
18 Universal Meditech Inc. II Oct-23-2023
19 Versea Diagnostics LLC II Sep-03-2021
20 bioMerieux, Inc. II Dec-28-2021
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