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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nucleic-acid tests used for infectious disease screening of blood and plasma donations
Regulation Description Test requirements.
Definition For the qualitative detection of nucleic acid for infectious disease agents in human specimens.
Product CodeQHO
Regulation Number 610.40
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 1 1
2020 9 9
2021 14 14
2022 10 10
2023 12 12
2024 11 11
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 44 44
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Output Problem 6 6
Non Reproducible Results 4 4
False Positive Result 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 11 11
No Consequences Or Impact To Patient 5 5
Hepatitis 4 4
No Known Impact Or Consequence To Patient 3 3
Test Result 2 2
No Patient Involvement 1 1

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