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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
2020 6 6
2021 10 10
2022 7 7
2023 10 10
2024 7 7
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 42 42
Incorrect Measurement 14 14
Low Test Results 12 12
Non Reproducible Results 5 5
Compatibility Problem 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 49 49
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 2 2

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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