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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
2014 2 2
2015 1 1
2016 3 3
2017 4 4
2018 4 4
2019 9 9
2020 6 6
2021 10 10
2022 7 7
2023 10 10
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 45 45
Low Test Results 11 11
Incorrect Measurement 11 11
Non Reproducible Results 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 12 12
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Feb-05-2024
2 Siemens Healthcare Diagnostics II Jun-02-2012
3 Siemens Healthcare Diagnostics, Inc II Apr-19-2017
4 Tosoh Bioscience Inc II Jun-05-2018
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