Events

Recall of West Nile Virus IgM Capture ELISA

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

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
    50701
  • Event Risk Class
    Class 2
  • Event Number
    Z-1014-2012
  • Event Initiated Date
    2008-10-08
  • Event Date Posted
    2012-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76225
  • 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
    It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. internal quality assurance testing has shown that the products are performing within the release specifications, although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta.
  • Action
    Inverness Medical sent an Urgent In Vitro Diagnostic Recall letter dated October 6, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use, destroy any unused or partially used test kits of the affected lot(s), and complete the table and certification of compliance. Customers were asked to fax back the completed form to inverness Medical at 1-609-527-8054. Replacement stock would be forwarded to them at no cost when the new lot becomes available. For questions regarding this recall call 609-627-8038.

Device

West Nile Virus IgM Capture ELISA
  • Model / Serial
    Lot 07262 (Canada), and Lot 08118 (Four customers in USA)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including ND, PA, TX, MN; and the country of Canada
  • Product Description
    West Nile Virus IgM Capture ELISA || The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.
  • Manufacturer
    Inverness Medical

Manufacturer

Inverness Medical
  • Manufacturer Address
    Inverness Medical, 532 Seventeen Mile Rocks Rd, Sinnamon Park Australia
  • Source
    USFDA