Events

Recall of ETEST Teicoplanin 256 (TP) SPB and Foam packaging. 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-01530-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01530-1
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp., biomerieux observed an underestimation of mic values by at least 1 dilution for coagulase negative staphylococci (cons); even though the mic essential agreement at +/- 1 dilution is > 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp.This underestimation leads to a risk of false susceptible results linked, in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study, the false susceptible rate observed was 37.5% for cons, where strains with an mic at 8 mg/l, by the reference method (resistant) can be found susceptible by etest teicoplanin.
  • Action
    biomerieux is advising users to stop using ETEST Teicoplanin for testing of CoNS and use an alternative method. The test can continue to be used with other microorganisms. For tests previously performed, users are advised to identify any possible false susceptible results that may have occurred, to analyse the related risks and to determine appropriate actions, if relevant.

Device

ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)Reference Number: 412461 & 522018Multiple serial numbers affectedARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd