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
system, test, thyroid autoantibody
Product Code
JZO
Regulation Number
866.5870
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIAGNOSTIC HYBRIDS, INC.
SUBSTANTIALLY EQUIVALENT
2
PHADIA AB
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
THERATEST LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
4
4
2016
8
8
2017
12
12
2018
35
35
2019
39
39
2020
17
17
2021
19
19
2022
25
25
2023
33
33
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
122
122
Low Test Results
41
41
Non Reproducible Results
26
26
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Incorrect Or Inadequate Test Results
7
7
Incorrect Measurement
5
5
False Negative Result
2
2
Manufacturing, Packaging or Shipping Problem
2
2
False Positive Result
2
2
Device Ingredient or Reagent Problem
1
1
Output Problem
1
1
Insufficient Information
1
1
High Readings
1
1
False Reading From Device Non-Compliance
1
1
Precipitate in Device or Device Ingredient
1
1
Low Readings
1
1
No Apparent Adverse Event
1
1
Failure to Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
94
94
No Consequences Or Impact To Patient
78
78
No Known Impact Or Consequence To Patient
41
41
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Ireland Limited
III
Jun-08-2023
2
Roche Diagnostics Operations, Inc.
II
Sep-17-2020
3
Siemens Healthcare Diagnostics, Inc
II
Apr-27-2019
4
Siemens Healthcare Diagnostics, Inc.
II
May-23-2024
5
Siemens Healthcare Diagnostics, Inc.
II
Sep-27-2022
6
Tosoh Bioscience Inc
II
Mar-08-2021
7
Tosoh Bioscience, Inc.
III
May-15-2017
-
-