Events

Recall of Device Recall Influenza Transport Swab

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quidel Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76337
  • Event Risk Class
    Class 2
  • Event Number
    Z-1231-2017
  • Event Initiated Date
    2017-01-25
  • Event Date Posted
    2017-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152840
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Respiratory virus panel nucleic acid assay system - Product Code OCC
  • Reason
    Quidel corporation is recalling influenza transport swab packages because it may include an incorrect sample swab mixed in with the proper swabs.
  • Action
    Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate of Destruction form and return to Quidel. Contact Quidel Technical Support at technicalsupport@quidel.com or by calling 800.874.1517 (in the U.S.), or 858.552.1100 (outside the U.S.), for instructions on how to obtain replacement product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time.

Device

Device Recall Influenza Transport Swab
  • Model / Serial
    PS10171
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
  • Product Description
    Influenza Transport Swab Packages, Reference #20171, || One lot with 1010 packages (each package contains 25 transport tubes). || The Influenza Swabs in dry transport tubes are intended for use with influenza tests
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Manufacturer Address
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Manufacturer Parent Company (2017)
    Quidel Corporation
  • Source
    USFDA