Events

Recall of West Nile Virus IgG DxSelect

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

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
    63387
  • Event Risk Class
    Class 3
  • Event Number
    Z-0182-2013
  • Event Initiated Date
    2012-10-03
  • Event Date Posted
    2012-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113653
  • 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
    Elisa, antibody, west nile virus - Product Code NOP
  • Reason
    The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
  • Action
    Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900.

Device

West Nile Virus IgG DxSelect
  • Model / Serial
    Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
  • Product Description
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G || Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen || Wells, Catalog Number EL0351, Lot Number 121117. || 510(k) No. K031953 || The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Manufacturer Address
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA