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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)
2017 2018 2019 2020 2021 2022
57 73 36 53 60 56

MDR Year MDR Reports MDR Events
2017 88 88
2018 112 112
2019 191 191
2020 139 139
2021 147 147
2022 115 115

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 266 266
False Negative Result 165 165
High Test Results 130 130
No Apparent Adverse Event 112 112
Low Test Results 46 46
Adverse Event Without Identified Device or Use Problem 43 43
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Incorrect Or Inadequate Test Results 24 24
Non Reproducible Results 13 13
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 1 1
Incorrect Measurement 1 1
High Readings 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 436 436
No Clinical Signs, Symptoms or Conditions 266 266
No Consequences Or Impact To Patient 89 89
Hepatitis 4 4
Insufficient Information 2 2
Vomiting 1 1
Misdiagnosis 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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