Events

Recall of Device Recall Sofia Influenza A B FIA, Kit 20218

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
    64017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0819-2013
  • Event Initiated Date
    2012-12-03
  • Event Date Posted
    2013-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115438
  • 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
    Antigens, cf (including cf control), influenza virus a, b, c - Product Code GNX
  • Reason
    Quidel corporation has initiated a voluntary recall of specific lots of the sofia influenza a+b fia kits because of false positive results which may lead to misdiagnosis.
  • Action
    Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.

Device

Device Recall Sofia Influenza A B FIA, Kit 20218
  • Model / Serial
    Lot # Range: 208228-214385, 707916-708108 (29 lots).
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
  • Product Description
    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
  • Manufacturer
    Quidel Corporation

Manufacturer

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