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TPLC
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Device
method, nephelometric, immunoglobulins (g, a, m)
Product Code
CFN
Regulation Number
866.5510
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE GROUP LTD
SUBSTANTIALLY EQUIVALENT
8
THE BINDING SITE GROUP LTD.
SUBSTANTIALLY EQUIVALENT
5
THE BINDING SITE GROUP, LTD.
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE, LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
2
2
2017
4
4
2018
2
2
2019
8
8
2022
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
10
10
Low Test Results
5
5
Adverse Event Without Identified Device or Use Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
14
14
No Clinical Signs, Symptoms or Conditions
2
2
No Consequences Or Impact To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jul-24-2024
2
Beckman Coulter Inc.
II
Aug-31-2023
3
SIEMENS HEALTHCARE DIAGNOSTICS INC
II
Oct-14-2022
4
Siemens Healthcare Diagnostics, Inc.
II
Feb-07-2024
5
Siemens Healthcare Diagnostics, Inc.
III
Mar-17-2015
6
The Binding Site Group, Ltd.
II
Feb-19-2020
7
The Binding Site Group, Ltd.
II
Dec-13-2018
8
The Binding Site Group, Ltd.
II
Nov-17-2018
9
The Binding Site Group, Ltd.
III
Jul-27-2017
10
The Binding Site Group, Ltd.
II
Jan-23-2017
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