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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
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
15
15
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
6
6
High Test Results
5
5
Incorrect Measurement
3
3
Chemical Problem
2
2
No Device Output
1
1
Circuit Failure
1
1
Display Difficult to Read
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
23
23
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
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