Events

Recall of Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. 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 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-00380-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00380-1
  • 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 by the manufacturer remel europe, part of thermo fisher scientific, have confirmed that this batch of group b reagent may produce weak or slow reactions. continued use of this batch may result in a failure to identify beta-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
  • Action
    Laboratories are requested to cease using and destroy the kits containing the affected reagent. This action has been closed-out on 08/08/2016.

Device

Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitr...
  • Model / Serial
    Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitro diagnostic medical device (IVD)Remel PathoDx Strep Grouping Kit 60 Test (R62025) Lot 1470133 Remel PathoDx Strep B Group Latex Lot 1437729ARTG number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand