Events

Recall of VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by In Vitro Technologies 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-00086-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00086-1
  • 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
    Possible visible and/or sub-visible microbial contamination of sample diluent was identified following a customer notification. internal testing has shown filtration of sample diluent using a 0.2 micron filter does not cause any significant change in performance of the diluent and therefore may be employed by the customer.
  • Action
    Internal testing by The Binding Site has shown that filtration of the sample diluent using a 0.2 micron filter does not cause any significant change in the performance of the diluent and therefore may be employed by the customer to remove the physical matter that may be present. It is strongly recommended that the filter and any alternative receptacles used are both as clean as possible in order to prevent any further potential for contamination of the product. This action has been closed-out on 03/08/2016.

Device

VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016

Manufacturer

In Vitro Technologies Pty Ltd