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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 860 860
2021 610 610
2022 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 727 727
False Negative Result 554 554
Incorrect, Inadequate or Imprecise Resultor Readings 176 176
Low Test Results 29 29
Non Reproducible Results 15 15
High Test Results 14 14
Adverse Event Without Identified Device or Use Problem 9 9
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
Device Misassembled During Manufacturing /Shipping 2 2
Incorrect Measurement 2 2
Off-Label Use 2 2
Product Quality Problem 1 1
Nonstandard Device 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Output Problem 1 1
High Readings 1 1
Insufficient Information 1 1
Missing Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 996 996
No Known Impact Or Consequence To Patient 297 297
No Consequences Or Impact To Patient 116 116
Insufficient Information 85 85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Test Result 7 7
Virus 5 5
No Code Available 4 4
Headache 2 2
Fever 1 1
Tingling 1 1
Cough 1 1
Viral Infection 1 1
Sore Throat 1 1
Reaction 1 1
Numbness 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1

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 Jul-12-2022
16 PROTERIXBIO II May-11-2022
17 Sky Medical Supplies and Equipments LLC II Feb-16-2021
18 Thera Test Laboratories, Inc. II Aug-27-2021
19 Thera Test Laboratories, Inc. II Aug-27-2021
20 Versea Diagnostics LLC II Sep-03-2021
21 bioMerieux, Inc. II Dec-28-2021
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