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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, free thyroxine
Product CodeCEC
Regulation Number 862.1695
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK USA INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 40 40
2015 166 166
2016 148 148
2017 196 196
2018 199 199
2019 167 216
2020 106 130
2021 96 96
2022 81 81
2023 99 99
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 865 922
Incorrect Or Inadequate Test Results 196 196
Low Test Results 126 131
Non Reproducible Results 89 100
Incorrect, Inadequate or Imprecise Result or Readings 68 68
Adverse Event Without Identified Device or Use Problem 27 27
Incorrect Measurement 12 12
Calibration Problem 7 7
High Readings 3 3
False Positive Result 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Optical Problem 1 1
Output Problem 1 1
False Negative Result 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 610 610
No Known Impact Or Consequence To Patient 410 479
No Clinical Signs, Symptoms or Conditions 309 309
Insufficient Information 9 9
No Code Available 5 5
Misdiagnosis 4 4
Test Result 3 7
No Patient Involvement 2 2
Atrial Fibrillation 1 1
Dysphagia/ Odynophagia 1 1
Polymyositis 1 1
Radiation Exposure, Unintended 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 Dec-22-2018
2 Beckman Coulter Inc. II Jun-02-2020
3 Beckman Coulter Inc. II Jun-28-2017
4 Beckman Coulter Inc. II Apr-11-2011
5 Beckman Coulter Inc. II Oct-01-2010
6 Qualigen Inc II Dec-19-2013
7 Siemens Healthcare Diagnostics, Inc. II May-04-2018
8 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
9 Tosoh Bioscience Inc II Jun-05-2018
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