Events

Recall of Spaplus Weekly wash Protocol and Bottles. 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 In Vitro Technologies 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-01502-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01502-1
  • 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, the binding site, have identified that the barcode label for the affected lot is incorrect and will not be recognised by the spaplus instrument. this lot number cannot be used to complete the weekly wash. there is no clinical impact associated with this issue.
  • Action
    In Vitro Technologies is advising users to quarantine and dispose of any remaining units of the affected product.

Device

Spaplus Weekly wash Protocol and Bottles. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Spaplus Weekly wash Protocol and Bottles. An in vitro diagnostic medical device (IVD)Item Number: TBSIK050SLot Number: 415451ARTG Number: 201721
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd