Events

Recall of BBL DrySlide Oxidase 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
    65089
  • Event Risk Class
    Class 2
  • Event Number
    Z-1423-2013
  • Event Initiated Date
    2013-04-12
  • Event Date Posted
    2013-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117862
  • 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
    Discs, strips and reagents, microorganism differentiation - Product Code JTO
  • Reason
    In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
  • Action
    BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inquiries to BD Technical Services at 1-800-638-8663.

Device

BBL DrySlide Oxidase kit
  • Model / Serial
    Oxidase kit - lot 2222008 with expiration date 08/31/13
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
  • Product Description
    BBL DrySlide Oxidase Kit, catalog number 231746 || Product Usage: || Presumptive diagnostic aid for gram-negative bacteria.
  • 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