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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, free thyroxine
Regulation Description Free thyroxine test system.
Product CodeCEC
Regulation Number 862.1695
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 96 96
2022 81 81
2023 99 99
2024 276 280
2025 213 222
2026 70 87

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 680 707
Low Test Results 86 89
Incorrect, Inadequate or Imprecise Result or Readings 48 48
Non Reproducible Results 43 43
Incorrect Measurement 14 14
False Positive Result 6 6
Output Problem 2 2
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Signal Artifact/Noise 1 1
Chemical Problem 1 1
Erratic Results 1 1
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Optical Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 806 836
No Consequences Or Impact To Patient 19 19
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Polymyositis 1 1

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