Events

Recall of ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.

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-00470-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00470-1
  • 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 categorization for streptococcus viridans group and streptococcus pneumoniae based on 2017 clsi and eucast breakpoints, which could lead to false susceptible result instead of resistant results on etest etp32 blister packaging when comparing to the broth-micro dilution (bmd) reference method.
  • Action
    bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.

Device

ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial sus...
  • Model / Serial
    ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.Reference Number: 531600 Multiple Lot NumbersARTG Number:187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd