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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
2017 151 151
2018 365 365
2019 343 378
2020 209 220
2021 120 120
2022 123 123
2023 131 131
2024 37 44

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 699 746
Low Readings 298 298
Low Test Results 278 282
Non Reproducible Results 83 85
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Incorrect Or Inadequate Test Results 69 69
Incorrect Measurement 11 11
Device Ingredient or Reagent Problem 9 9
Adverse Event Without Identified Device or Use Problem 7 7
High Readings 5 5
Output Problem 4 4
Leak/Splash 2 2
Chemical Problem 2 2
Insufficient Information 2 2
False Positive Result 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1
Optical Problem 1 1
Failure to Calibrate 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 424 467
No Clinical Signs, Symptoms or Conditions 388 397
No Consequences Or Impact To Patient 362 362
No Patient Involvement 297 297
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Radiation Exposure, Unintended 2 2
Misdiagnosis 2 2
Test Result 2 3
No Code Available 1 1
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 Jun-28-2017
4 Beckman Coulter, Inc. II Apr-20-2023
5 QUIDELORTHO II May-14-2024
6 Siemens Healthcare Diagnostics, Inc II Feb-26-2018
7 Tosoh Bioscience Inc II Dec-22-2018
8 Tosoh Bioscience Inc II Jun-05-2018
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