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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
2016 150 150
2017 151 151
2018 365 365
2019 343 378
2020 209 220
2021 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 536 576
Low Readings 298 298
Low Test Results 248 252
Incorrect Or Inadequate Test Results 104 104
Incorrect, Inadequate or Imprecise Resultor Readings 60 60
Non Reproducible Results 52 54
Adverse Event Without Identified Device or Use Problem 13 13
Device Ingredient or Reagent Problem 9 9
High Readings 5 5
Incorrect Measurement 2 2
Output Problem 2 2
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1
Failure to Calibrate 1 1
False Reading From Device Non-Compliance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 468 468
No Known Impact Or Consequence To Patient 464 507
No Patient Involvement 297 297
No Clinical Signs, Symptoms or Conditions 69 71
No Information 4 4
Test Result 2 3
Radiation Exposure, Unintended 2 2
Misdiagnosis 2 2
No Code Available 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Jun-30-2016
5 Siemens Healthcare Diagnostics, Inc II Feb-26-2018
6 Tosoh Bioscience Inc II Dec-22-2018
7 Tosoh Bioscience Inc II Jun-05-2018
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