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TPLC
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Device
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
Product Code
LBS
Regulation Number
862.1475
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
CAROLINA LIQUID CHEMISTRIES CORP.
SUBSTANTIALLY EQUIVALENT
1
ELITECHGROUP SEPPIM S.A.S.
SUBSTANTIALLY EQUIVALENT
1
LIPOSCIENCE, INC
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POLYMEDCO, INC.
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES LTD
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
4
4
2019
2
2
2020
1
1
2021
1
1
2022
2
2
2023
5
5
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
11
11
Non Reproducible Results
8
8
High Test Results
6
6
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Output Problem
2
2
Leak/Splash
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
No Consequences Or Impact To Patient
5
5
No Known Impact Or Consequence To Patient
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
III
Sep-10-2016
2
Beckman Coulter Inc.
II
May-12-2017
3
Ortho-Clinical Diagnostics
II
Nov-15-2013
4
Ortho-Clinical Diagnostics
II
Mar-26-2012
5
Roche Diagnostics Operations, Inc.
II
Jun-27-2015
6
Siemens Healthcare Diagnostics, Inc.
II
May-11-2016
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