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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
radioimmunoassay, estradiol
Product Code
CHP
Regulation Number
862.1260
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
38
38
2019
36
39
2020
135
135
2021
43
43
2022
61
61
2023
42
42
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
183
186
Low Test Results
82
82
Incorrect, Inadequate or Imprecise Result or Readings
59
59
Non Reproducible Results
36
36
No Apparent Adverse Event
14
14
Incorrect Measurement
11
11
Device Damaged Prior to Use
2
2
Incorrect Or Inadequate Test Results
2
2
Calibration Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Markings/Labelling Problem
1
1
Material Integrity Problem
1
1
Low Readings
1
1
Unable to Obtain Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
129
132
No Clinical Signs, Symptoms or Conditions
106
106
No Code Available
39
39
No Consequences Or Impact To Patient
39
39
Insufficient Information
35
35
Overdose
4
4
Therapeutic Response, Increased
2
2
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Misdiagnosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Ireland Diagnostics Division
II
May-16-2019
2
Abbott Ireland Diagnostics Division
II
Dec-22-2018
3
Biomerieux Inc
II
Jan-04-2023
4
Siemens Healthcare Diagnostics, Inc
II
Feb-04-2018
5
Siemens Healthcare Diagnostics, Inc.
II
Apr-29-2022
6
Siemens Healthcare Diagnostics, Inc.
II
Feb-24-2020
7
Siemens Healthcare Diagnostics, Inc.
II
Jul-13-2018
8
Tosoh Bioscience Inc
II
Jun-05-2018
9
bioMerieux, Inc.
II
Dec-28-2021
-
-