Events

Recall of Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Saraya 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-00139-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00139-1
  • 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
    During storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°c for longer than 14 days. as a result, the shelf life of the test strips may be affected. use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required.
  • Action
    Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature. This action has been closed-out on 01/03/2018.

Device

Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER...
  • Model / Serial
    Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)All stock currently in the marketARTG number: 170540
  • Manufacturer
    Saraya Australia Pty Ltd

Manufacturer

Saraya Australia Pty Ltd