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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, human growth hormone
Regulation Description Human growth hormone test system.
Product CodeCFL
Regulation Number 862.1370
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 2 2
2022 6 6
2023 4 4
2024 5 5
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 16 16
High Test Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Hormonal Imbalance 2 2

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