Events

Recall of Gram Crystal Violet stain MV1031

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia & New Zealand.

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-00869-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-09-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00869-1
  • 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
    Investigations have confirmed that this batch may be contaminated with an environmental gram-negative bacillus. continued use of this batch may result in the appearance that those cultures being stained include a gram-negative rod, or that otherwise sterile samples may contain gram-negative rods.
  • Action
    Laboratories are requested to cease use and discard the affected lot of Gram Crystal Violet. This action has been closed-out on 04/03/2016.

Device

Gram Crystal Violet stain MV1031

Manufacturer

Thermo Fisher Scientific Australia & New Zealand