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
enzymatic esterase--oxidase, cholesterol
Product Code
CHH
Regulation Number
862.1175
Device Class
1
Premarket Reviews
Manufacturer
Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
MEDICON HELLAS, S.A
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
1
1
2021
2
2
2022
4
4
2023
4
4
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
Non Reproducible Results
11
11
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Low Test Results
7
7
High Test Results
5
5
Incorrect Measurement
3
3
Chemical Problem
2
2
Circuit Failure
1
1
Display Difficult to Read
1
1
Erratic Results
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
24
24
No Consequences Or Impact To Patient
6
6
Insufficient Information
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Dec-20-2021
2
Polymer Technology Systems, Inc.
III
Aug-05-2019
3
Polymer Technology Systems, Inc.
II
May-23-2019
4
Randox Laboratories Ltd.
II
Jul-20-2022
5
Randox Laboratories Ltd.
II
Dec-01-2021
-
-