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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorometric, cortisol
Product CodeJFT
Regulation Number 862.1205
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 3 3
2019 6 6
2020 4 4
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 14 14
Low Test Results 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Non Reproducible Results 2 2
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Tosoh Bioscience Inc II Jun-05-2018
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