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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 antigen, b surface antigen, be antigen)
Definition In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.
Product CodeLOM
Regulation Number 866.3172
Device Class 2

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
49 57 69 63 52 68

MDR Year MDR Reports MDR Events
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 197 197
2025 333 333

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 475 475
False Negative Result 336 336
High Test Results 192 192
Low Test Results 79 79
Non Reproducible Results 58 58
Incorrect, Inadequate or Imprecise Result or Readings 31 31
No Apparent Adverse Event 22 22
Incorrect Measurement 9 9
Output Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Leak/Splash 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Chemical Problem 1 1
Device Contamination with Body Fluid 1 1
Device Damaged Prior to Use 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 979 979
No Known Impact Or Consequence To Patient 103 103
No Consequences Or Impact To Patient 35 35
Insufficient Information 7 7
Hepatitis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Ortho-Clinical Diagnostics, Inc. II Jun-13-2024
3 Ortho-Clinical Diagnostics, Inc. II Jan-19-2024
4 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
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