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
analyzer, chemistry, centrifugal, for clinical use
Product Code
JJG
Regulation Number
862.2140
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2018
1
1
2020
86
86
2021
12
12
2022
4
4
2023
5
5
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Emits Odor
48
48
Smoking
42
42
Noise, Audible
8
8
Computer Software Problem
6
6
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Low Readings
5
5
Temperature Problem
5
5
High Readings
4
4
Output Problem
4
4
No Device Output
4
4
Low Test Results
3
3
Excessive Heating
3
3
Mechanical Jam
2
2
Operating System Version or Upgrade Problem
1
1
Sparking
1
1
Material Integrity Problem
1
1
Measurement System Incompatibility
1
1
Device Contamination with Body Fluid
1
1
High Test Results
1
1
Failure to Cycle
1
1
Erratic or Intermittent Display
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
78
78
No Clinical Signs, Symptoms or Conditions
26
26
Insufficient Information
4
4
Misdiagnosis
1
1
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abaxis Inc
II
Jun-12-2020
-
-