Events

Recall of The Binding Site SPAPLuS analyser. 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-2014-RN-00150-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00150-1
  • 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
    In vitro technologies have been notified by the manufacturer that the “prog error (overflow) det comm” pop-up message has been recently reported on a number of the spaplus analysers with the ‘c’ suffix on the serial number. when the error occurs, analysis will stop and a full shutdown is required to restart testing. in addition to this, it causes results to be lost and the test will be required to be repeated.
  • Action
    In Vitro Technologies are advising users that a build up of static is the cause of the issue. A grounding unit will be installed on all affected units to prevent the error from occurring.

Device

The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)All serial numbers with ‘C’ suffix Catalogue number: TBSIE610ARTG Number: 201723
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd