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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.
  SUBSTANTIALLY EQUIVALENT 3
BD
  SUBSTANTIALLY EQUIVALENT 3
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 2
PRINCETON BIOMEDITECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2

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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 32 32
Incorrect, Inadequate or Imprecise Result or Readings 30 30
False Negative Result 5 5
Inaccurate Information 2 2
Shipping Damage or Problem 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
Fluid/Blood Leak 1 1
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 3 3
Test Result 1 1
Taste Disorder 1 1
Discomfort 1 1
Malaise 1 1
Respiratory Tract Infection 1 1
Sudden Cardiac Death 1 1
Chemical Exposure 1 1
Death 1 1
Headache 1 1
Pain 1 1
Pneumonia 1 1
Chills 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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