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
lymphocyte separation medium
Product Code
JCF
Regulation Number
864.8500
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
5
5
2018
34
34
2019
16
16
2020
8
8
2021
10
10
2022
7
7
2023
4
4
2024
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
51
51
Device Ingredient or Reagent Problem
25
25
Break
15
15
Leak/Splash
7
7
Device Contamination with Chemical or Other Material
6
6
Incorrect Or Inadequate Test Results
5
5
Volume Accuracy Problem
5
5
Short Fill
4
4
Fracture
2
2
Material Deformation
1
1
Device Operates Differently Than Expected
1
1
Coagulation in Device or Device Ingredient
1
1
Component Missing
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
53
53
No Known Impact Or Consequence To Patient
48
48
No Consequences Or Impact To Patient
11
11
No Information
4
4
No Code Available
1
1
No Patient Involvement
1
1
Exposure to Body Fluids
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Aug-22-2014
2
Sigma-Aldrich Mfg LLC
II
Mar-04-2010
3
Sigma-Aldrich Mfg LLC
II
Mar-04-2010
-
-