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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
2014 111 111
2015 158 158
2016 150 150
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 968 1015
Low Readings 298 298
Low Test Results 295 299
Incorrect Or Inadequate Test Results 254 254
Incorrect, Inadequate or Imprecise Result or Readings 88 88
Non Reproducible Results 83 85
Nonstandard Device 62 62
Adverse Event Without Identified Device or Use Problem 13 13
Incorrect Measurement 11 11
Device Ingredient or Reagent Problem 9 9
Insufficient Information 6 6
High Readings 6 6
Output Problem 4 4
Component Missing 3 3
Leak/Splash 2 2
Chemical Problem 2 2
False Positive Result 2 2
Device Damaged Prior to Use 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Calibrate 1 1
Device Operates Differently Than Expected 1 1
Optical Problem 1 1
False Reading From Device Non-Compliance 1 1
Unable to Obtain Readings 1 1
Human-Device Interface Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 612 612
No Known Impact Or Consequence To Patient 581 624
No Clinical Signs, Symptoms or Conditions 388 397
No Patient Involvement 297 297
Test Result 78 79
No Information 8 8
Not Applicable 6 6
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Radiation Exposure, Unintended 2 2
Misdiagnosis 2 2
No Code Available 1 1
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Feb-04-2019
2 Abbott Ireland Diagnostics Division II Dec-03-2014
3 Beckman Coulter Inc. II Jun-02-2020
4 Beckman Coulter Inc. II Jun-28-2017
5 Beckman Coulter Inc. II Jun-30-2016
6 Beckman Coulter Inc. II Oct-07-2015
7 Beckman Coulter Inc. III Aug-20-2012
8 Beckman Coulter, Inc. II Apr-20-2023
9 ORTHO-CLINICAL DIAGNOSTICS III Jun-04-2015
10 QUIDELORTHO II May-14-2024
11 Siemens Healthcare Diagnostics II Jan-30-2014
12 Siemens Healthcare Diagnostics, Inc II Feb-26-2018
13 Tosoh Bioscience Inc II Dec-22-2018
14 Tosoh Bioscience Inc II Jun-05-2018
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