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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 7

MDR Year MDR Reports MDR Events
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 201 201
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 328 328
False Negative Result 256 256
High Test Results 156 156
Low Test Results 52 52
Non Reproducible Results 23 23
No Apparent Adverse Event 22 22
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Leak/Splash 3 3
Insufficient Information 3 3
Improper or Incorrect Procedure or Method 2 2
Appropriate Term/Code Not Available 2 2
Incorrect Measurement 2 2
Device Contamination with Body Fluid 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 666 666
No Known Impact Or Consequence To Patient 103 103
No Consequences Or Impact To Patient 35 35
Insufficient Information 6 6
Hepatitis 1 1
Vomiting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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