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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
2018 14 14
2019 7 7
2020 5 5
2021 2 2
2022 7 7
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 28 28
Low Test Results 5 5
Non Reproducible Results 4 4
Display or Visual Feedback Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper Chemical Reaction 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 16 16
No Known Impact Or Consequence To Patient 11 11
No Clinical Signs, Symptoms or Conditions 11 11

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