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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)
2020 2021 2022 2023 2024 2025
53 60 70 63 52 15

MDR Year MDR Reports MDR Events
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 201 201
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 332 332
False Negative Result 262 262
High Test Results 162 162
Low Test Results 54 54
Non Reproducible Results 24 24
No Apparent Adverse Event 22 22
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Leak/Splash 3 3
Insufficient Information 3 3
Incorrect Measurement 2 2
Appropriate Term/Code Not Available 2 2
Improper or Incorrect Procedure or Method 2 2
Chemical Problem 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 683 683
No Known Impact Or Consequence To Patient 103 103
No Consequences Or Impact To Patient 35 35
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hepatitis 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Jun-13-2024
2 Ortho-Clinical Diagnostics, Inc. II Jan-19-2024
3 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
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