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TPLC
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show TPLC since
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Device
lipase hydrolysis/glycerol kinase enzyme, triglycerides
Product Code
CDT
Regulation Number
862.1705
Device Class
1
Premarket Reviews
Manufacturer
Decision
LIPOSCIENCE
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES LIMITED
SUBSTANTIALLY EQUIVALENT
1
SEPPIM S.A.S.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
6
6
2016
12
12
2017
3
3
2018
4
4
2019
2
2
2020
2
2
2022
4
4
2023
8
8
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Ingredient or Reagent Problem
12
12
Non Reproducible Results
12
12
High Test Results
10
10
Low Test Results
10
10
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Incorrect Or Inadequate Test Results
3
3
Incorrect Measurement
2
2
Output Problem
1
1
Electrical /Electronic Property Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
21
21
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
8
8
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc
II
Mar-02-2020
2
Beckman Coulter Inc.
II
Oct-24-2019
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
Horiba Instruments Inc
II
Feb-02-2016
7
Ortho-Clinical Diagnostics
II
Oct-17-2016
8
Ortho-Clinical Diagnostics
II
Dec-22-2014
9
Randox Laboratories Ltd.
II
May-04-2018
10
Randox Laboratories Ltd.
II
Oct-18-2016
11
Roche Diagnostics Operations, Inc.
II
Jun-27-2015
12
Siemens Healthcare Diagnostics, Inc.
II
Aug-29-2023
13
Siemens Healthcare Diagnostics, Inc.
II
Nov-02-2021
14
Siemens Healthcare Diagnostics, Inc.
II
May-14-2016
15
Siemens Healthcare Diagnostics, Inc.
II
May-11-2016
16
Siemens Healthcare Diagnostics, Inc.
II
Mar-24-2010
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