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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 26 26
2021 93 93
2022 116 116
2023 155 155
2024 45 45
2025 61 61
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 465 465
False Negative Result 49 49
Non Reproducible Results 4 4
Leak/Splash 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 490 490
No Known Impact Or Consequence To Patient 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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