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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
Product CodeCFP
Regulation Number 862.1405
Device Class 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 6 6
2021 10 10
2022 7 7
2023 10 10
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 39 39
Incorrect Measurement 12 12
Low Test Results 10 10
Non Reproducible Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Feb-05-2024
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