Events

Recall of Haemophilus Test medium (HTM). 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-00831-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00831-1
  • 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 have received reports regarding an issue with the use of the 04054 haemophilus test medium. (lot number hdk-206). the issue is related to the media not supporting the growth of haemophilus influenza isolates (atcc 49766 and atcc 49247).
  • Action
    bioMérieux is requesting Customers cease using lot number HDK-206 (04054 Haemophilus Test medium). It is also recommended that results which have an ongoing clinical impact be re- examined using a different lot number of 04054 Haemophilus Test medium. Distribute this information to all appropriate personnel in your laboratory including others to whom you may have transferred the product, retain a copy in your files. 2. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. 3. Quarantine inventory of 04054 Haemophilus Test medium (HTM) for Lot # HDK-206 and discard all affected products in an appropriate manner. Please complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt and credit.

Device

Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)Product Number: 04054Lot Number: HDK-206ARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd