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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, identification, hepatitis b antigen
Product CodeKSJ
Device Class 3

MDR Year MDR Reports MDR Events
2019 65 65
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 34 34
False Negative Result 17 17
High Test Results 15 15
Low Test Results 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 61 61
No Code Available 6 6
No Consequences Or Impact To Patient 5 5

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