Events

Recall of Oxoid AST Disc - Ceftazidime CAZ10. 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-01190-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01190-1
  • 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, part of thermo fisher scientific, has confirmed that the concentration of antibiotic in thermoscientific oxoid caz10 ceftazidime, ct1629b (specific lots) may decrease over shelf life if not stored frozen. specifically, antibiotic degradation has been identified in product stored at 8°c between 2 and 3 years of shelf life. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for ceftazimide.
  • Action
    1. Users are to inspect stocks and remove from further use all units from the nominated batch number, then complete the supplied Facsimile Reply Form a for a credit note to be issued. 2. Complete the supplied facsimile Reply Form even if there is no remaining stock subject to recall, so as to reconcile this process.

Device

Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)Product Code: CT1629BLot Numbers: 1883326, 1849729, 1814258, 1786239, 1752930, 1728103, 1683346, 1646438, 1611709, 1571939, 1562018, and 1558378ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand