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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
Product CodeCDP
Regulation Number 862.1710
Device Class 2

MDR Year MDR Reports MDR Events
2019 343 378
2020 209 220
2021 120 120
2022 123 123
2023 131 131
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 464 504
Low Readings 212 212
Low Test Results 170 174
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Non Reproducible Results 68 70
Incorrect Measurement 10 10
Output Problem 3 3
Insufficient Information 2 2
High Readings 2 2
False Positive Result 2 2
Leak/Splash 2 2
Chemical Problem 2 2
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Optical Problem 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 374 376
No Consequences Or Impact To Patient 227 227
No Patient Involvement 212 212
No Known Impact Or Consequence To Patient 131 174
Test Result 2 3
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Feb-04-2019
2 Beckman Coulter Inc. II Jun-02-2020
3 Beckman Coulter, Inc. II Apr-20-2023
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