TPLC - Total Product Life Cycle

• 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