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 Code	LOM
Regulation Number	866.3172
Device Class	2

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
57	69	63	52	68	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	555	555
False Negative Result	347	347
High Test Results	213	213
Non Reproducible Results	106	106
Low Test Results	101	101
Incorrect, Inadequate or Imprecise Result or Readings	34	34
Incorrect Measurement	14	14
Improper or Incorrect Procedure or Method	10	10
Output Problem	7	7
Leak/Splash	4	4
Insufficient Device Problem Information	4	4
Chemical Problem	2	2
Contamination /Decontamination Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Device Contamination with Body Fluid	1	1
Device Damaged Prior to Use	1	1
Unable to Obtain Readings	1	1
Device Difficult to Maintain	1	1
Calibration Problem	1	1
Device Damaged Prior to Receipt by User	1	1
No Apparent Adverse Event	1	1
Inadequate or Insufficient Training	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1230	1230
Insufficient Information	7	7
No Known Impact Or Consequence To Patient	6	6
Hepatitis	3	3
Exposure to Body Fluids	1	1
Vomiting	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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