Events

Recall of BD DifcoTM Neisseria Meningitidis Antiserum Group Y

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

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
    46750
  • Event Risk Class
    Class 3
  • Event Number
    Z-1561-2008
  • Event Initiated Date
    2007-09-06
  • Event Date Posted
    2008-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68217
  • 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
    Meningitidis Antisera - Product Code GTJ
  • Reason
    Exhibits cross reactivity with neisseria meningitides group w135.
  • Action
    BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.

Device

BD DifcoTM Neisseria Meningitidis Antiserum Group Y
  • Model / Serial
    Lot #6104713, EXP 2009-02-26
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of New Zealand.
  • Product Description
    BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units || For use in slide agglutination tests for serotyping Neisseria Meningitidis.
  • Manufacturer
    BD Diagnostic Systems / Lee Laboratories

Manufacturer

BD Diagnostic Systems / Lee Laboratories
  • Manufacturer Address
    BD Diagnostic Systems / Lee Laboratories, 1475 Athens Hwy, Grayson GA 30017-1538
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA