Events

Recall of Parechovirus r-gene. 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-2015-RN-00579-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00579-1
  • 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
    An internal investigation identified a shift of the ct values of lnternal control (ic1 w0, internal control with water) inside and outside the limit of specifications. the investigations performed by r&d; with ref. 71-020 lot 1002978600 showed that ct values results on the extraction control (ic1w0) with ct value close to the specification of validity (32 ct) or just above this specification. the ct shift values may be observed on a positive sample without impacting the limit of detection.
  • Action
    Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.

Device

Parechovirus r-gene. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Parechovirus r-gene. An in vitro diagnostic medical device (IVD)Catalogue Number: 71-020Serial Number: 1002978600Supplied as Research Use OnlyARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd