Events

Recall of Remel Xpect Clostridium difficile Toxin A/B. An vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Oxoid 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-2012-RN-00909-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00909-1
  • 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
    Investigations have confirmed that some units of the reagents in these lots may contain microbial contamination that could impact assay procedure and/or performance.
  • Action
    Laboratories to inspect stock and remove from use any units from affected lot numbers. Previous results issued from these lots should be reviewed.

Device

Remel Xpect Clostridium difficile Toxin A/B. An vitro diagnostic medical device (IVD)
  • Model / Serial
    Remel Xpect Clostridium difficile Toxin A/B. An vitro diagnostic medical device (IVD)R24650 - Lot number: 131988R24640 - Lot number: 141764
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd