TPLC - Total Product Life Cycle

• Device: antigens, all groups, streptococcus spp.
• Product Code: GTY
• Regulation Number: 866.3740
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BINAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALGEN SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
QUIDEL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2017	2	2
2018	12	12
2019	6	6
2020	1	1
2021	37	37
2022	32	32
2023	44	44
2024	16	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	59	59
False Negative Result	43	43
Incorrect, Inadequate or Imprecise Result or Readings	33	33
Break	3	3
Fire	2	2
Defective Component	2	2
Component Missing	1	1
Defective Device	1	1
Chemical Spillage	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inaccurate Information	1	1
Missing Information	1	1
Leak/Splash	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
No Consequences Or Impact To Patient	21	21
No Code Available	3	3
Choking	2	2
Bacterial Infection	2	2
No Information	2	2
Abdominal Pain	1	1
Unspecified Infection	1	1
Red Eye(s)	1	1
Chemical Exposure	1	1
No Known Impact Or Consequence To Patient	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alere San Diego	II	Feb-22-2012
2	Biosite Inc Dba Innovacon Inc.	II	Feb-22-2011
3	Jay Bird Investments Inc	II	Aug-23-2011
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
5	Remel Inc	II	Aug-07-2015