Events

Recall of Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. 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-2017-RN-01441-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01441-1
  • 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
    Thermo fisher scientific, has confirmed that shigella sonnei (phases 1& 2) agglutinating serum may fail to agglutinate within the specified minimum reaction time when tested with shigella sonnei phase 2 bacteria. continued use of these lots may result in a failure to correctly identify isolates as shigella sonnei phase 2.The products continue to correctly identify shigella sonnei phase 1 bacteria.
  • Action
    Thermo fisher is advising users to inspect stock and remove any remaining units of the affected batches from use. A review of previously generated patient results is at the discretion of the Laboratory Manager.

Device

Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic...
  • Model / Serial
    Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic medical device (IVD) Product code: R30164201Lot Numbers: 1465529, 2118879, 2173683, 2161363, 2149414, 2135578, 1738564, 1957305, 1947930, 1847285ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand