Events

Recall of Device Recall BBL TM LYSINE IRON AGAR

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
    61006
  • Event Risk Class
    Class 2
  • Event Number
    Z-1108-2012
  • Event Initiated Date
    2012-01-11
  • Event Date Posted
    2012-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107173
  • 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
    Culture media, antimicrobial susceptibility test - Product Code LKA
  • Reason
    Lysine iron agar may not produce the correct biochemical reactions with quality control organisms over the shelf life of the product.
  • Action
    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated January 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining packages. A form was attached for customers to complete and return via fax to: Attention: Regulatory Compliance at 410-316-4258. Contact the BD Technical Services Department at 1-800-638-8663 for questions regarding this recall.

Device

Device Recall BBL TM LYSINE IRON AGAR
  • Model / Serial
    Lot number 0204203 Exp. 3/31/14
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TX, VA, and WI, and the countries of Belgium, Canada, Chile, China, Columbia, Costa Rica, Mexico, El Salvador, Ecuador, Japan, Manila, Singapore, Peru, Taiwan, and Venezuela.
  • Product Description
    BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. || Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
  • 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