Events

Recall of Fluoprep (Mounting medium for immunofluorescence microscopy) - 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-2013-RN-00834-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00834-1
  • 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
    Biomerieux has advised that some units in lot 1001818920 of fluoprep (reference 75521) may be to too thick and is difficult or impossible to spread on the slide.
  • Action
    End users are requested to discard any product that is too thick to effectively use and contact bioMerieux to organise for replacement stock.

Device

Fluoprep (Mounting medium for immunofluorescence microscopy) - An in vitro diagnostic medical dev...
  • Model / Serial
    Fluoprep (Mounting medium for immunofluorescence microscopy) - An in vitro diagnostic medical device (IVD).Reference: 75521Lot number: 1001818920Expiry date: 28/11/2013
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd