Events

Recall of BD, Salmonella Flagellar d Antigen (Typhoid H)

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

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
    30443
  • Event Risk Class
    Class 3
  • Event Number
    Z-0315-05
  • Event Initiated Date
    2004-10-20
  • Event Date Posted
    2004-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35880
  • 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, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
  • Reason
    Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
  • Action
    Consignees were notified by letter beginning 10/20/2004.

Device

BD, Salmonella Flagellar d Antigen (Typhoid H)
  • Model / Serial
    Catalogue #240785, Lot #2192844 & Lot # 2270533
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan
  • Product Description
    BD, Salmonella Flagellar d Antigen (Typhoid H)
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems
  • Manufacturer Address
    BD Diagnostic Systems, 1475 Athens Hwy, Grayson GA 30017-1538
  • Source
    USFDA