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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Product CodeMLA
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 4 4
2023 3 3
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 12 12
False Negative Result 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21

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