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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, acth
Regulation Description Adrenocorticotropic hormone (ACTH) test system.
Product CodeCKG
Regulation Number 862.1025
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 2 2
2019 8 8
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 9 9
Low Test Results 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 6 6
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Tosoh Bioscience Inc II Dec-22-2018
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