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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)
2019 2020 2021 2022 2023 2024
36 53 60 70 64 13

MDR Year MDR Reports MDR Events
2019 191 191
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 321 321
False Negative Result 229 229
High Test Results 152 152
No Apparent Adverse Event 94 94
Low Test Results 36 36
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Non Reproducible Results 14 14
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 2 2
Incorrect Measurement 1 1
High Readings 1 1
Chemical Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 508 508
No Known Impact Or Consequence To Patient 271 271
No Consequences Or Impact To Patient 55 55
Insufficient Information 6 6
Hepatitis 4 4
Vomiting 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
2 Ortho-Clinical Diagnostics, Inc. II Jan-19-2024
3 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
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