Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
radioimmunoassay, free thyroxine
Product Code
CEC
Regulation Number
862.1695
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
1. K123379
ABBOTT ARCHITECT FREE T4
2. K173122
Abbott Architect Free T4
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
122
122
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
926
983
Incorrect Or Inadequate Test Results
196
196
Low Test Results
129
134
Non Reproducible Results
90
101
Incorrect, Inadequate or Imprecise Result or Readings
70
70
Adverse Event Without Identified Device or Use Problem
27
27
Incorrect Measurement
13
13
Calibration Problem
7
7
False Positive Result
4
4
High Readings
3
3
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
373
373
Insufficient Information
11
11
No Code Available
5
5
Misdiagnosis
4
4
Test Result
3
7
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Atrial Fibrillation
1
1
Dysphagia/ Odynophagia
1
1
Polymyositis
1
1
Radiation Exposure, Unintended
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
-
-