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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
2020 209 220
2021 120 120
2022 123 123
2023 131 131
2024 41 56
2025 23 41

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 394 437
Low Test Results 91 91
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Low Readings 77 77
Non Reproducible Results 56 64
Incorrect Measurement 11 11
Chemical Problem 4 4
Output Problem 4 4
Leak/Splash 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 413 448
No Consequences Or Impact To Patient 108 108
No Patient Involvement 76 76
No Known Impact Or Consequence To Patient 43 51
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Test Result 2 3
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Beckman Coulter, Inc. II Apr-20-2023
3 QUIDELORTHO II May-14-2024
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