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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, total triiodothyronine
Regulation Description Total triiodothyronine test system.
Product CodeCDP
Regulation Number 862.1710
Device Class 2

MDR Year MDR Reports MDR Events
2021 120 120
2022 123 123
2023 131 131
2024 41 56
2025 25 43

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 339 372
Low Test Results 52 52
Incorrect, Inadequate or Imprecise Result or Readings 46 46
Non Reproducible Results 40 47
Incorrect Measurement 11 11
Low Readings 5 5
Chemical Problem 4 4
Leak/Splash 2 2
Output Problem 2 2
Insufficient Information 2 2
False Positive Result 2 2
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Optical Problem 1 1
Appropriate Term/Code Not Available 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 413 446
No Consequences Or Impact To Patient 21 21
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Known Impact Or Consequence To Patient 1 1
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Apr-20-2023
2 QUIDELORTHO II May-14-2024
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