Events

Recall of OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.

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-00291-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00291-1
  • 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 oxoid limited, part of thermo fisher scientific, has confirmed that the performance of antibiotic in thermoscientific oxoid ct1412b cpo30 cefpirome may decrease when stored over 2°c after 24 months. the product has a registered shelf life of 36 months. performance remains unaffected throughout shelf life when stored at -20°c to +2°c. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for cefpirome.
  • Action
    Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.

Device

OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.
  • Model / Serial
    OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device. Lot Numbers:1611705, 1693625ARTG Number: 208273Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand