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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
2016 3 3
2017 4 4
2018 4 4
2019 9 9
2020 6 6
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 27 27
Low Test Results 6 6
Incorrect Measurement 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Apr-19-2017
2 Tosoh Bioscience Inc II Jun-05-2018
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