Events

Recall of Horse Blood Agar. 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-2018-RN-00353-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00353-1
  • 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 an issue at their brisbane culture media manufacturing site regarding product reference number 04059, lot number jcu-203, horse blood agar. during post release testing a potential contamination issue (contaminated deep and surface) has been identified. the microorganism was identified as a gram positive bacilli.
  • Action
    bioMérieux is requesting that Laboratories should: 1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines; 2.Complete and return Attachment A from the customer letter to qa.anz@biomerieux.com in order to confirm receipt; and 3.Contact your local bioMérieux representative for product compensation as necessary.

Device

Horse Blood Agar. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Horse Blood Agar. An in vitro diagnostic medical device (IVD)Reference Number: 04059Lot Number: JCU-203ARTG Number: :201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd