TPLC - Total Product Life Cycle

• Device: antigens, cf (including cf control), influenza virus a, b, c
• Product Code: GNX
• Regulation Number: 866.3330
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
QUIDEL CORP.
	SUBSTANTIALLY EQUIVALENT	2
QUIDEL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REMEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SA SCIENTIFIC LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEKISUI DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	3	3
2017	1	1
2018	2	2
2021	36	36
2022	32	32
2023	61	61
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	115	115
Incorrect, Inadequate or Imprecise Result or Readings	18	18
False Negative Result	3	3
Improper or Incorrect Procedure or Method	1	1
Detachment Of Device Component	1	1
Leak/Splash	1	1
Break	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Expiration Date Error	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	132	132
No Consequences Or Impact To Patient	4	4
Death	2	2
No Code Available	2	2
Misdiagnosis	2	2
No Information	1	1
Chemical Exposure	1	1
Respiratory Tract Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Princeton Biomeditech Corp	II	Aug-31-2012
2	Quidel Corporation	II	Feb-14-2013
3	Remel Inc	III	Aug-13-2013