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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, identification, hepatitis b antigen
Product CodeKSJ
Device Class 3

MDR Year MDR Reports MDR Events
2016 30 30
2017 71 71
2018 79 79
2019 65 65
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 129 129
False Negative Result 57 57
High Test Results 30 30
Incorrect Or Inadequate Test Results 23 23
Low Test Results 14 14
High Readings 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 193 193
No Consequences Or Impact To Patient 47 47
No Code Available 8 8
Valvular Stenosis 1 1
No Information 1 1
Hepatitis 1 1
Overdose 1 1

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