Events

Recall of Device Recall BBL Crystal Enteric/Nonfermenter ID Kit

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
    63958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0699-2013
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115111
  • 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
    Kit, identification, enterobacteriaceae - Product Code JSS
  • Reason
    In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
  • Action
    Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD notification to all end users. Contact the BD Customer Service Department at 1-800-638-8663 if further assistance is required.

Device

Device Recall BBL Crystal Enteric/Nonfermenter ID Kit
  • Model / Serial
    Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium.
  • Product Description
    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. || The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
  • 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