Events

Recall of BBL" OXACILLIN SCREEN 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
    58906
  • Event Risk Class
    Class 2
  • Event Number
    Z-2608-2011
  • Event Initiated Date
    2011-04-20
  • Event Date Posted
    2011-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100500
  • 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, mueller hinton agar/broth - Product Code JTZ
  • Reason
    Oxacillin screen agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.
  • Action
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers. The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced. Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908.

Device

BBL" OXACILLIN SCREEN AGAR
  • Model / Serial
    Lot 1034119 Exp. 2011/05/03
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.
  • Product Description
    BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. || Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.
  • 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