TPLC - Total Product Life Cycle

• Device: test, qualitative and quantitative factor deficiency
• Product Code: GGP
• Regulation Number: 864.7290
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DIAGNOSTICA STAGO, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	4
INSTRUMENTATION LABORATORY COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PRECISION BIOLOGIC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION BIOLOGIC INC.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2017	3	3
2018	3	3
2019	1	1
2021	2	2
2022	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	5	5
High Test Results	4	4
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Off-Label Use	1	1
Device Operates Differently Than Expected	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8	8
No Clinical Signs, Symptoms or Conditions	6	6
No Information	1	1
Missing Value Reason	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Diagnostica, Inc.	II	Apr-21-2010
2	Aniara Diagnostica LLC	II	Mar-06-2023
3	Diagnostica Stago, Inc.	II	Apr-10-2020
4	Helena Laboratories, Inc.	II	Oct-12-2018
5	Instrumentation Laboratory Co.	II	Feb-01-2016
6	Instrumentation Laboratory Co.	II	May-10-2012
7	Sekisui Diagnostics Llc	II	Dec-03-2012
8	Sekisui Diagnostics Llc	II	Sep-20-2012
9	Siemens Healthcare Diagnostics, Inc.	II	Dec-22-2015