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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
radioimmunoassay, estradiol
Regulation Description
Estradiol test system.
Product Code
CHP
Regulation Number
862.1260
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
135
135
2021
43
43
2022
61
61
2023
60
60
2024
67
67
2025
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
222
222
Low Test Results
91
91
Non Reproducible Results
63
63
Incorrect, Inadequate or Imprecise Result or Readings
49
49
Incorrect Measurement
20
20
Low Readings
4
4
High Readings
3
3
Material Integrity Problem
2
2
Insufficient Information
2
2
Failure to Calibrate
2
2
Calibration Problem
2
2
Mechanical Problem
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Defective Device
1
1
Device Damaged Prior to Use
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
197
197
No Known Impact Or Consequence To Patient
86
86
Insufficient Information
35
35
No Code Available
32
32
No Consequences Or Impact To Patient
17
17
Overdose
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Therapeutic Response, Increased
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomerieux Inc
II
Jan-04-2023
2
Siemens Healthcare Diagnostics, Inc.
II
Apr-29-2022
3
Siemens Healthcare Diagnostics, Inc.
II
Feb-24-2020
4
bioMerieux, Inc.
II
Dec-28-2021
-
-