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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 3 3
2019 6 6
2020 4 4
2021 2 2
2022 2 2
2023 9 9
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 20 20
Non Reproducible Results 8 8
Low Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Incorrect Or Inadequate Test Results 2 2
Output Problem 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Apr-09-2012
2 Siemens Healthcare Diagnostics, Inc. II May-03-2023
3 Tosoh Bioscience Inc II Jun-05-2018
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