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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 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 728 728
False Negative Result 557 557
Incorrect, Inadequate or Imprecise Result or Readings 176 176
Low Test Results 29 29
Failure to Calibrate 16 16
Non Reproducible Results 15 15
High Test Results 14 14
Unable to Obtain Readings 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Improper or Incorrect Procedure or Method 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Erratic Results 4 4
No Apparent Adverse Event 3 3
Incorrect Measurement 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Off-Label Use 2 2
Missing Test Results 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Nonstandard Device 1 1
Retraction Problem 1 1
Use of Device Problem 1 1
Insufficient Information 1 1
Output Problem 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1021 1021
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
Sore Throat 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Fever 1 1
Cough 1 1
Numbness 1 1
Palpitations 1 1
Cognitive Changes 1 1
Tingling 1 1
Viral Infection 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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