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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
Product CodeCDX
Regulation Number 862.1700
Device Class 2

MDR Year MDR Reports MDR Events
2014 4 4
2015 5 5
2016 4 4
2017 7 7
2018 14 14
2019 7 7
2020 5 5
2021 2 2
2022 7 7
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 52 52
Non Reproducible Results 8 8
Low Test Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 3 3
Incorrect Measurement 2 2
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
False Positive Result 1 1
Chemical Problem 1 1
Improper Chemical Reaction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 27 27
No Clinical Signs, Symptoms or Conditions 23 23
No Known Impact Or Consequence To Patient 19 19
Radiation Exposure, Unintended 1 1
Misdiagnosis 1 1

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