TPLC - Total Product Life Cycle

• Device: devices detecting influenza a, b, and c virus antigens
• Definition: An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
• Product Code: PSZ
• Regulation Number: 866.3328
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCESS BIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	2
SEKISUI DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	1	1
2020	5	5
2021	41	41
2022	10	10
2023	12	12
2024	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	36	36
Incorrect, Inadequate or Imprecise Result or Readings	31	31
False Negative Result	4	4
Inaccurate Information	2	2
Device Ingredient or Reagent Problem	1	1
Shipping Damage or Problem	1	1
Component Missing	1	1
Break	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Material Integrity Problem	1	1
Detachment of Device or Device Component	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	70
No Consequences Or Impact To Patient	9	9
No Known Impact Or Consequence To Patient	3	3
Death	1	1
Test Result	1	1
Malaise	1	1
Taste Disorder	1	1
Chemical Exposure	1	1
Chills	1	1
Discomfort	1	1
Pain	1	1
Pneumonia	1	1
Sudden Cardiac Death	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	II	Feb-09-2022
2	Becton Dickinson & Co.	II	May-10-2019
3	Quidel Corporation	II	Nov-06-2020