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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor,test,hiv-1
Product CodeMTL
Device Class 3

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Cross Reactivity 1 1
False Negative Result 1 1
Incorrect Or Inadequate Test Results 1 1
Loss of Data 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Test Result 1 1
No Information 1 1
Insufficient Information 1 1

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