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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

Device Problems
High Test Results 11
Low Test Results 7
Adverse Event Without Identified Device or Use Problem 1
Device Ingredient Or Reagent 1
Total Device Problems 20

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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