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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, syphilis, treponemal
Product CodeMTN
Device Class Not Classified

MDR Year MDR Reports MDR Events
2016 17 17
2017 26 26
2018 22 22
2019 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 59 59
Low Test Results 23 23
False Positive Result 16 16
Incorrect Or Inadequate Test Results 4 4
Low Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 74 74
No Code Available 16 16
No Consequences Or Impact To Patient 13 13
No Information 1 1

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