Events

Recall of BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson Pty Ltd.

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
    RC-2018-RN-00072-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00072-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    As a result of continuous surveillance on antimicrobial resistance, becton dickinson (bd) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (ast) results to colistin.The labelling currently provided with the bd gram negative panels (nmic) panels indicates that colistin susceptibility can be determined. emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the bd nmic panels with bd phoenix instrumentation.
  • Action
    BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product. BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50; instrument customers where rules can be created in the software to identify resistant isolates.

Device

BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)
  • Model / Serial
    BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)Catalogue Number: 448788 Lot Numbers: ALLARTG Number 197287 (Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd