Events

Safety Alert Or Field Safety Notices for Oxoid antimicrobial susceptibility testing discs (AST)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Thermofisher Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/014
  • Event Number
    CON251944
  • Date
    2013-03-20
  • Event Date Posted
    2013-03-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON251944?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    The manufacturer has issued nine field safety notices since november 2011 recalling batches of ast disc, due to the presence of non-impregnated or ‘blank’ ast discs manufactured before december 2012. ast discs may, therefore, not perform to the expected specification. blank discs could lead to a false indication of antibiotic resistance, which in turn could lead to delayed reporting, reduced options for treatment or unnecessary changes to treatment. recent recalls of oxoid ast discs have been in response to the potential for the presence of non-impregnated or ‘blank’ discs within specific disc lots. the manufacturer estimates that the rate of occurrence of blank discs is less than 1 in 100,000. there have been nine field safety notices on this issue since november 2011, with four occurring in february 2013.  more information can be found on the mhra website.
  • Action
    When reviewing results which do not fit the clinical picture (i.e. unexpected pattern of resistance within classes of antibiotic, discrepant results with MIC testing or unexpected patient outcomes on empirical therapy) consider if blank AST discs are a possible cause.   Consider the need for repeat and/or further testing of resistant isolates, including, where appropriate, non-disc methods,  especially in clinically severe cases and where there are reduced options for treatment due to high levels of resistance in your patients. Report any suspected examples of blank discs observed in your laboratory to the MHRA and the manufacturer. Medical microbiologists and microbiology laboratory managers.

Device

Oxoid antimicrobial susceptibility testing discs (AST)
  • Model / Serial
  • Product Description
    Oxoid antimicrobial susceptibility testing discs (AST), manufactured by Thermofisher Scientific.
  • Manufacturer
    Thermofisher Scientific

Manufacturer

Thermofisher Scientific