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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, total thyroxine
Regulation Description Total thyroxine test system.
Product CodeCDX
Regulation Number 862.1700
Device Class 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2022 7 7
2023 12 12
2024 8 10
2025 8 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 30 33
Non Reproducible Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Chemical Problem 3 3
Incorrect Measurement 3 3
Low Test Results 3 3
False Positive Result 2 2
Mechanical Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Low Readings 1 1
Appropriate Term/Code Not Available 1 1
Improper Chemical Reaction 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 39
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 DRG International, Inc. III Aug-04-2025
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