Events

Recall of Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). 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-2014-RN-00159-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00159-1
  • 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 identified that the affected etest strips do not give the correct minimum inhibitory concentration (mic) for some quality control strains, with the mic results out of range (high) according to the mic specification described in the quality control procedure.The mic results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the mic.
  • Action
    bioMerieux is advising users to discontinue use and destroy affected stock. Replacement kits will be provided once a new batch is available.

Device

Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagn...
  • Model / Serial
    Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagnostic medical device (IVD)Product Reference Number:531618Lot Number: 1002054430Reference /Lot Number inside packaging: 51103168, 1001897090Product Reference Number: 531610Lot Number: 1000853690, 1001960650Reference /Lot Number inside packaging: 51103610, 1001895910, 51103160, 1001895910Product Reference Number: 412332Lot Number: 1002110560, 1002389880ARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd