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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
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
2017 1 1
2018 1 1
2020 9 9
2021 14 14
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 17 17
False Negative Result 15 15
Output Problem 6 6
Non Reproducible Results 4 4
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Insufficient Information 8 8
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Test Result 2 2
Hepatitis 2 2
No Code Available 1 1
No Patient Involvement 1 1

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