Events

Recall of OXOID AST DISC CT0159B – Oxacillin OX1. 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-2018-RN-00361-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00361-1
  • 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 have identified that some packs of oxoid ox1 oxacillin, ct0159b, may contain individual cartridges of a different product, i.E. ct0417b, cro30 ceftriaxone.Each individual cartridge is correctly labelled.
  • Action
    Thermo Fisher are advising customers to inspect stock, remove from further use and discard all stock of the impacted lot number.

Device

OXOID AST DISC CT0159B – Oxacillin OX1. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    OXOID AST DISC CT0159B – Oxacillin OX1. An in vitro diagnostic medical device (IVD). Lot Number: 2248254ARTG Number: 208273(Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand