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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)
2018 2019 2020 2021 2022 2023
73 36 53 60 70 22

MDR Year MDR Reports MDR Events
2018 112 112
2019 191 191
2020 139 139
2021 147 147
2022 139 139
2023 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 296 296
False Negative Result 196 196
High Test Results 159 159
No Apparent Adverse Event 112 112
Low Test Results 52 52
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Adverse Event Without Identified Device or Use Problem 13 13
Non Reproducible Results 12 12
Incorrect Or Inadequate Test Results 10 10
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 2 2
Incorrect Measurement 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 399 399
No Known Impact Or Consequence To Patient 361 361
No Consequences Or Impact To Patient 76 76
Insufficient Information 6 6
Hepatitis 5 5
Vomiting 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
2 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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