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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
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
2019 4 4
2020 26 26
2021 93 93
2022 116 116
2023 155 155
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 362 362
False Negative Result 33 33
High Test Results 2 2
Low Test Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 364 364
No Known Impact Or Consequence To Patient 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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