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-2014-RN-01014-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01014-1
  • 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
    Biomerieux have identified the product may contain low level contamination in some plates. contaminants were identified as (1) bacillus cereus, (2) hafniaalvei, and (3) staphylococcus epidermidis.
  • Action
    bioMérieux requested the customers to inspect the above product prior to use and discard any plates found to be contaminated. Complimentary replacement stock has been shipped in the same quantity as originally provided. This action was undertaken prior to approval of the recall strategy by the TGA.

Device

Horse Blood Agar. An in vitro Diagnostic Medical Device (IVD)
  • Model / Serial
    Horse Blood Agar. An in vitro Diagnostic Medical Device (IVD)Product Reference: 04059Batch Number: EHU-302Expiry Date: 2014-10-23ARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd