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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, detection, bacterial, for platelet transfusion products
Regulation Description Microbial growth monitor.
Product CodeMZC
Regulation Number 866.2560
Device Class 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 6 6
2023 2 2
2024 5 5
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 10 10
False Positive Result 9 9
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Missing Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Sepsis 2 2

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