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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorometric, cortisol
Regulation Description Cortisol (hydrocortisone and hydroxycorticosterone) test system.
Product CodeJFT
Regulation Number 862.1205
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 9 9
2024 5 5
2025 10 10
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 16 16
Non Reproducible Results 13 13
Low Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 2 2
Incorrect Measurement 1 1
Material Integrity Problem 1 1
Optical Problem 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29

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