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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, immunoreactive insulin
Regulation Description Immunoreactive insulin test system.
Product CodeCFP
Regulation Number 862.1405
Device Class 1

MDR Year MDR Reports MDR Events
2021 10 10
2022 7 7
2023 10 10
2024 7 7
2025 17 17
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 47 47
Low Test Results 16 16
Incorrect Measurement 14 14
Non Reproducible Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Feb-05-2024
2 DRG International, Inc. II Jan-15-2025
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