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
centrifuges (micro, ultra, refrigerated) for clinical use
Product Code
JQC
Regulation Number
862.2050
Device Class
1
Premarket Reviews
Manufacturer
Decision
BIOMET BIOLOGICS, INC.
SUBSTANTIALLY EQUIVALENT
2
EMCYTE CORPORATION
SE - WITH LIMITATIONS
1
HARVEST TECHNOLOGIES, CORP.
SUBSTANTIALLY EQUIVALENT
1
KAYLIGHT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
112
112
2015
130
130
2016
70
70
2017
31
31
2018
10
10
2019
7
7
2020
4
4
2021
1
1
2022
1
1
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
124
124
Thermal Decomposition of Device
82
82
Device Inoperable
81
81
Device Operates Differently Than Expected
78
78
Detachment Of Device Component
45
45
Charred
41
41
Material Fragmentation
35
35
Smoking
23
23
Melted
14
14
Device Emits Odor
13
13
Inadequate User Interface
12
12
Device Expiration Issue
11
11
Mechanical Problem
10
10
Difficult to Open or Close
5
5
Circuit Failure
4
4
Defective Component
4
4
Use of Device Problem
4
4
Failure to Align
4
4
Fire
3
3
Detachment of Device or Device Component
3
3
Crack
3
3
Improper or Incorrect Procedure or Method
3
3
Component Falling
2
2
Noise, Audible
2
2
Failure To Service
2
2
Device Stops Intermittently
2
2
Overheating of Device
2
2
Expiration Date Error
2
2
Insufficient Information
2
2
Unintended Electrical Shock
2
2
Device Displays Incorrect Message
2
2
Electrical /Electronic Property Problem
2
2
Electrical Shorting
2
2
Misconnection
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Burst Container or Vessel
2
2
Device Contamination with Body Fluid
2
2
Sparking
2
2
Device Slipped
2
2
Leak/Splash
2
2
Obstruction of Flow
1
1
Component Missing
1
1
Device Maintenance Issue
1
1
Failure to Power Up
1
1
Fracture
1
1
Loss of Power
1
1
Device Issue
1
1
Electronic Property Issue
1
1
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
216
216
No Known Impact Or Consequence To Patient
85
85
No Consequences Or Impact To Patient
29
29
Not Applicable
12
12
No Information
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Electric Shock
5
5
Eye Injury
4
4
Death
2
2
No Code Available
2
2
Injury
2
2
Hearing Impairment
1
1
Incomplete Induced Abortion
1
1
Nausea
1
1
Hearing Loss
1
1
Venipuncture
1
1
Bone Fracture(s)
1
1
Physical Entrapment
1
1
Headache
1
1
Thromboembolism
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jul-23-2016
2
Becton Dickinson & Co.
III
Mar-11-2010
3
Biomet, Inc.
III
Apr-17-2009
4
Global Focus Marketing & Develop
I
Jul-27-2011
5
Iris Diagnostics
II
Dec-23-2014
6
LW Scientific, Inc.
II
Mar-23-2019
7
StatSpin, Inc., dba Iris Sample Processing
II
May-10-2011
8
StatSpin, Inc., dba Iris Sample Processing
I
Mar-04-2010
9
Terumo BCT, Inc.
II
Nov-16-2017
-
-