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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product CodeLOM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
49 46 124 127 46 46 38 46 57 73 36 53 60 70 64 13

MDR Year MDR Reports MDR Events
2014 129 129
2015 139 139
2016 146 146
2017 88 88
2018 112 112
2019 191 191
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 453 453
False Negative Result 321 321
High Test Results 210 210
Adverse Event Without Identified Device or Use Problem 120 120
No Apparent Adverse Event 112 112
Low Test Results 86 86
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Incorrect Or Inadequate Test Results 78 78
Non Reproducible Results 15 15
Nonstandard Device 7 7
Detachment Of Device Component 7 7
Use of Incorrect Control/Treatment Settings 7 7
Incorrect Measurement 5 5
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 3 3
High Readings 3 3
Device Operates Differently Than Expected 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Problem 2 2
False Device Output 2 2
False Reading From Device Non-Compliance 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Unexpected Therapeutic Results 1 1
Naturally Worn 1 1
Device Displays Incorrect Message 1 1
Chemical Problem 1 1
Chemical Spillage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 734 734
No Clinical Signs, Symptoms or Conditions 508 508
No Consequences Or Impact To Patient 197 197
Insufficient Information 6 6
Test Result 6 6
Hepatitis 5 5
Venipuncture 2 2
Misdiagnosis 2 2
No Information 2 2
Missing Value Reason 1 1
Eye Injury 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-15-2009
2 Abbott Laboratories, Inc II Mar-25-2013
3 Bio-Rad Laboratories III Oct-21-2013
4 Bio-Rad Laboratories II Sep-17-2012
5 Bio-Rad Laboratories III May-20-2010
6 Diasorin Inc. II Mar-22-2011
7 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
8 Ortho-Clinical Diagnostics II Dec-20-2013
9 Ortho-Clinical Diagnostics III Apr-23-2013
10 Ortho-Clinical Diagnostics, Inc. II Jan-19-2024
11 Siemens Healthcare Diagnostics, Inc II Oct-21-2014
12 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
13 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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