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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device albumin, antigen, antiserum, control
Regulation Description Albumin immunological test system.
Product CodeDCF
Regulation Number 866.5040
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 4
2022 3 3
2023 5 5
2024 9 9
2025 12 12
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 16 16
High Test Results 10 11
Non Reproducible Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Measurement 2 2
Signal Artifact/Noise 1 1
Device Alarm System 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
High Readings 1 2
Unable to Obtain Readings 1 1
Infusion or Flow Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 34
Unspecified Eye / Vision Problem 1 1

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