Events

Recall of PREVI Isola System. 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 Biomerieux 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-00884-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00884-1
  • 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
    It has been determined that the previ isola system pipettor may fail to dispense a sample due to the pipettor becoming clogged. the resulting failure to dispense may be caused by all specimen types verified for use with the previ isola system.
  • Action
    Update to Instructions for Use (IFU) and software.

Device

PREVI Isola System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    PREVI Isola System. An in vitro diagnostic medical device (IVD) Catalogue Numbers: 29500 and 29500RAll lots affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd