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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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 621 634
Low Test Results 78 78
Incorrect, Inadequate or Imprecise Result or Readings 46 46
Non Reproducible Results 39 39
Incorrect Measurement 13 13
False Positive Result 6 6
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
Output Problem 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 736 749
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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