Events

Recall of Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30

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-2016-RN-01008-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01008-1
  • 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
    Biomérieux has been alerted via a european committee on antimicrobial susceptibility testing (eucast) warning letter about potential underestimation of the minimum inhibitory concentration (mic) values for enterobacteriaceae and acinetobacter when using the etest colistin gradient test. there is potential to obtain false susceptible results.Biomérieux have initiated a complaint investigation. the investigations are on-going, with the following identified to date:- etest colistin performance depends on the mueller hinton agar plate used. - for enterobacteriaceae strains, the performance conforms if used in conjunction with the mhe agar (from biomérieux) with a good concordance rate compared to broth-micro dilution method.- there is a potential of false susceptible results on etest colistin with some mueller hinton agar (except with the mhe agar from biomérieux for the enterobacteriaceae strains).
  • Action
    bioMérieux is advising users that for Enterobacteriaceae strains, to can continue to use Etest COLISTIN for diagnostic purposes, only if it is used with MH-E agar (Mueller Hinton-E agar from bioMérieux Ref. 413822-or the soon to be launched 04091 MHE agar in October 2016)). If not, or if strains other than Enterobacteriaceae are tested, bioMérieux recommend users restrict its use to epidemiological surveys. Among tests previously performed, it is recommended users identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.

Device

Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30
  • Model / Serial
    Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30Catalogue Number: 537300Etest COLISTIN CO 256 WW B100Catalogue Number: 537308Multiple Lot Numbers affected (see attached)ARTG Number: 187139An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd