Events

Recall of Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

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
    55867
  • Event Risk Class
    Class 3
  • Event Number
    Z-2025-2010
  • Event Initiated Date
    2010-05-19
  • Event Date Posted
    2010-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92092
  • 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
    In vitro diagnostic reagent to aid in the diagnosis of salmonellosis may exhibit decreased or no reactivity. if proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. if control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
  • Action
    The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form. Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,
  • Model / Serial
    Lot 9126057, Exp May 04, 2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to distributors nationwide and to affiliates in Belgium and Korea.
  • Product Description
    Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA