Events

Recall of Thermofisher Remel Bactipstaph Latex Kits

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-01410-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01410-1
  • 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
    An internal technical investigation by remel has confirmed that the positive control supplied within these kits may be non-reactive. the latex test reagent provided in the kits performs exactly as expected and according to specifications.No other batches or pack sizes of this product are affected.
  • Action
    Thermofisher is advising users to inspect stock and quarantine any remaining units of the affected batch from use. The requirement for a review of previously generated results is at the discretion of the Laboratory Director.

Device

Thermofisher Remel Bactipstaph Latex Kits
  • Model / Serial
    Thermofisher Remel Bactipstaph Latex Kits Items Numbers: R21143Lot Numbers: 104809ARTG number 235680 (Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate identification and testing IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand