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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device devices detecting influenza a, b, and c virus antigens
Regulation Description Influenza virus antigen detection test system.
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 CodePSZ
Regulation Number 866.3328
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 42 42
2022 10 10
2023 12 12
2024 16 16
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 68 68
Incorrect, Inadequate or Imprecise Result or Readings 51 51
False Negative Result 14 14
Device Markings/Labelling Problem 2 2
Inaccurate Information 2 2
Sparking 1 1
Device Ingredient or Reagent Problem 1 1
Break 1 1
Crack 1 1
Material Integrity Problem 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 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 9 9
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
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 Quidel Corporation II Nov-06-2020
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