Events

Recall of Device Recall In vitro diagnostic for influenza A and B.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inverness Medical BioStar 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
    49385
  • Event Risk Class
    Class 2
  • Event Number
    Z-0212-2009
  • Event Initiated Date
    2008-07-02
  • Event Date Posted
    2008-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73236
  • 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
    Cf Influenza Virus A, B, C Antigens - Product Code GNX
  • Reason
    Diagnostic kits for flu were distributed with incorrect components.
  • Action
    Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.

Device

Device Recall In vitro diagnostic for influenza A and B.
  • Model / Serial
    Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including state of IL.
  • Product Description
    BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
  • Manufacturer
    Inverness Medical BioStar Inc.

Manufacturer

Inverness Medical BioStar Inc.
  • Manufacturer Address
    Inverness Medical BioStar Inc., 331 S 104th St, Louisville CO 80027-9713
  • Source
    USFDA