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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
2019 6 6
2020 4 4
2021 2 2
2022 2 2
2023 9 9
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 15 15
Low Test Results 7 7
Non Reproducible Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Optical Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-03-2023
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