Events

Recall of AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain to selectively indicate Mycobacterium and other acid fast organisms)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-01161-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01161-1
  • 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
    Roche diagnostics has observed a staining artefact on slides stained with the afb iii staining kit. this artefact consists of a circular and a non-specific purple- to pink-coloured slide background staining, which in some cases is present within tissue elements and in other cases takes the form of circular deposits that appear to be above the tissue plane. the latter can occur both within the tissue-containing and blank portions of the slide. this artefact may interfere with the interpretation and identification of acid-fast bacteria, which is the indication for this assay. also, the artefact could be mistaken for acid-fast bacteria and lead to a false positive interpretation. a trained pathologist would recognise the artefacts and reject the slide without attempting to interpret it.
  • Action
    Roche Diagnostic Australia Pty Ltd is requesting the customers to identify and discard the affected lots and is providing credit for the affected lots that are discarded. Roche Diagnostic is also requesting the customers to consider the need to review patient results using the affected lots. This action has been closed-out on 12/08/2016.

Device

AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain ...
  • Model / Serial
    AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain to selectively indicate Mycobacterium and other acid fast organisms) Lot Numbers: D05755, D11015, E1024 and E03378ARTG Number 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited