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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 34 34
Incorrect Measurement 12 12
Low Test Results 7 7
Non Reproducible Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
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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