Events

Recall of ETEST XM256 (Cefuroxime) Foam and SPB. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia 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-2017-RN-00136-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00136-1
  • 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
    A biomérieux investigation has confirmed a potential performance issue on strain categorisation for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints based on 2016 clsi clinical standards. the potential hazard is to obtain minor error (susceptible instead of intermediate or intermediate instead of resistant) on strain categorisation for streptococcus pneumoniae and for enterobacteriaceae strains only when using the 2016 clsi clinical breakpoints defined for cefuroxime oral forms. products perform within specification when using the 2016 eucast guidelines.
  • Action
    bioMérieux is advising customers who use the 2016 CLSI clinical guidelines that they may continue to use the ETEST XM256 (Cefuroxime) Foam and SPB products and can directly report results for Streptococcus pneumoniae and Enterobacteriaeceae when oral breakpoints are used if they apply the reporting recommendations provided in the customer letter. bioMérieux is also advising that for tests previously performed, users are to identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.

Device

ETEST XM256 (Cefuroxime) Foam and SPB. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    ETEST XM256 (Cefuroxime) Foam and SPB. An in vitro diagnostic medical device (IVD).ETEST XM256 (Cefuroxime) WW SPB Reference Number: 412305 Lot Numbers: 1002884720 (Exp. 16 Jan 2017), 1003383650 (Exp. 27 Aug 2017)ETEST XM256 (Cefuroxime) WW Foam Reference Number: 506918 Lot Numbers: 1003075850 (Exp. 9 April 2017), 1003385930 (Exp. 27 Aug 2017)ARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd