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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, acth
Product CodeCKG
Regulation Number 862.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNODIAGNOSTIC SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 2 2
2019 8 8
2020 1 1
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 11 11
Low Test Results 3 3
Non Reproducible Results 3 3
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 6 6
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-20-2012
2 Tosoh Bioscience Inc II Dec-22-2018
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