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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
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
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 3
BD
  SUBSTANTIALLY EQUIVALENT 3
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON AND CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON, AND CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 8
BINAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INVERNESS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRINCETON BIOMEDITECH CORP.
  SUBSTANTIALLY EQUIVALENT 4
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
RESPONSE BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
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 5 5
Inaccurate Information 2 2
Device Ingredient or Reagent Problem 1 1
Break 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1
Fluid/Blood Leak 1 1
Material Integrity Problem 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Device Markings/Labelling Problem 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
Respiratory Tract Infection 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
4 Quidel Corporation II Mar-26-2018
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