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TPLC
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Device
enzymatic esterase--oxidase, cholesterol
Product Code
CHH
Regulation Number
862.1175
Device Class
1
Premarket Reviews
Manufacturer
Decision
ABAXIS, INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
ACON LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
3
ALFA WASSERMANN, INC.
SUBSTANTIALLY EQUIVALENT
1
AXIS-SHIELD POC AS
SUBSTANTIALLY EQUIVALENT
1
HITACHI CHEMICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
LABORATORY CORPORATION OF AMERICA HOLDINGS
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POLYMER TECHNOLOGY SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES, LTD.
SUBSTANTIALLY EQUIVALENT
1
VITAL DIAGNOSTICS PTY. LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
5
5
2017
2
2
2018
1
1
2019
5
5
2020
1
1
2021
2
2
2022
4
4
2023
4
4
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
8
8
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Non Reproducible Results
5
5
Low Test Results
3
3
Chemical Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Incorrect Or Inadequate Test Results
1
1
Circuit Failure
1
1
Display Difficult to Read
1
1
No Device Output
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
13
13
No Clinical Signs, Symptoms or Conditions
12
12
No Known Impact Or Consequence To Patient
2
2
Insufficient Information
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego
II
Feb-06-2012
2
Beckman Coulter Inc.
II
Dec-20-2021
3
Beckman Coulter Inc.
II
May-12-2017
4
Beckman Coulter Inc.
II
Jun-08-2016
5
Beckman Coulter Inc.
II
Jan-28-2015
6
Diagnostic Chemicals, Ltd.
III
Dec-16-2010
7
Horiba Instruments Inc
II
Feb-02-2016
8
Ortho-Clinical Diagnostics
II
Nov-15-2013
9
Polymer Technology Systems, Inc.
III
Aug-05-2019
10
Polymer Technology Systems, Inc.
II
May-23-2019
11
Polymer Technology Systems, Inc.
III
Apr-02-2010
12
Polymer Technology Systems, Inc.
II
Mar-15-2010
13
Polymer Technology Systems, Inc.
II
Mar-01-2010
14
Randox Laboratories Ltd.
II
Jul-20-2022
15
Randox Laboratories Ltd.
II
Dec-01-2021
16
Roche Diagnostics Operations, Inc.
II
Jun-27-2015
17
Siemens Healthcare Diagnostics, Inc.
II
May-11-2016
18
Sterling Diagnostics, Inc.
III
Dec-29-2016
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