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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)
2021 2022 2023 2024 2025 2026
57 69 63 52 68 0

MDR Year MDR Reports MDR Events
2021 147 147
2022 139 139
2023 163 163
2024 197 197
2025 384 384
2026 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 487 487
False Negative Result 318 318
High Test Results 193 193
Low Test Results 86 86
Non Reproducible Results 71 71
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Incorrect Measurement 8 8
Improper or Incorrect Procedure or Method 7 7
Output Problem 5 5
Leak/Splash 4 4
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
Device Difficult to Maintain 1 1
Calibration Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1079 1079
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 6 6
Hepatitis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Vomiting 1 1
Exposure to Body Fluids 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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