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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 42 57
2025 4 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 381 410
Low Test Results 89 89
Incorrect, Inadequate or Imprecise Result or Readings 78 78
Low Readings 77 77
Non Reproducible Results 53 61
Incorrect Measurement 10 10
Output Problem 4 4
Chemical Problem 3 3
False Positive Result 2 2
Insufficient Information 2 2
Leak/Splash 2 2
High Readings 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 396 417
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 2 2
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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