Events

Recall of EZTest steam and Smart-Read EZTest steam Biological Indicators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Austmel 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-2013-RN-00589-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00589-1
  • 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
    The manufacturer determined that the read out time is not within specification of the label claims on these lots. there is potential for delayed or incomplete colour change (false fail) at the indicated incubation time of 10 hours.
  • Action
    Austmel are asking customer to return all unused products for replacement with unaffected stock. If affected stock must be used, Austmel is advising end users to incubate the exposed biological indicator for a minimum of 72 hours.

Device

EZTest steam and Smart-Read EZTest steam Biological Indicators
  • Model / Serial
    EZTest steam and Smart-Read EZTest steam Biological IndicatorsLot numbers: S-444, SR-444, S-445, SR-445, S-447ARTG Number: 126974
  • Manufacturer
    Austmel Pty Ltd

Manufacturer

Austmel Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA