Events

Recall of Device Recall BBL Crystal Enteric/Nonfermentor (E/NF) Identification System

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
    68468
  • Event Risk Class
    Class 3
  • Event Number
    Z-2041-2014
  • Event Initiated Date
    2014-05-21
  • Event Date Posted
    2014-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127980
  • 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
    A portion of the bbl crystal enteric/nonfermentor (e/nf) identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. a portion of these kits contain crystal inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
  • Action
    BD Diagnostic sent an Urgent Product Recall letter dated May 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please discard any outer kit boxes that are labeled with the incorrect expiration date. All components of the kit will perform as expected with the expiration dates on each component. Our records indicate you may have been shipped a portion of the above-referenced product between August 23, 2013, and the present day. Please complete the attached form whether or not you have any inventory remaining so that we may acknowledge your receipt of this notification. It is not necessary to contact BD by telephone. Simply complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258. If further assistance is needed, please contact the BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact the BD Technical Services Department at 1-800-638-8663. Please accept our apology for any inconvenience this may cause. BD is committed to providing you with the highest quality products. Thank you for your continued support. : -" / 06 . ;/ i )!.U fJJ aLA. Thierry Guilltrt Gail Claiborne Marketing / Regulatory Compliance

Device

Device Recall BBL Crystal Enteric/Nonfermentor (E/NF) Identification System
  • Model / Serial
    Lot. Number - 3224281 / Exp. Date - 2014/06/09 ,  Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
  • Product Description
    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic 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., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA