Events

Recall of Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

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-01024-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01024-1
  • 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
    A technical investigation has confirmed that the affected lot contains insufficient concentration of penicillin. continued use of this product could result in the incorrect reporting of minimum inhibitory concentration against penicillin.
  • Action
    Thermo Fisher is advising users to inspect stocks and remove from use any remaining units of the affected lot number. Affected stock can be returned or destroyed for credit. Results issued with the affected lot number should be reviewed against case histories, other results and other relevant individual data. This action has been closed-out on 25/08/2016.

Device

Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

Manufacturer

Thermo Fisher Scientific Australia & New Zealand