Events

Safety Alert Or Field Safety Notices for ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc

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 Oxoid Ltd.

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 Number
    MDA/2017/034
  • Date
    2017-11-23
  • Event Date Posted
    2017-11-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/thermoscientifictm-oxoidtm-caz10-ceftazidime-ct1629b-antimicrobial-susceptibility-test-disc-potential-for-false-resistance-results-if-stored-at-the-wrong-temperature
  • 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
    Manufactured by oxoid ltd (thermofisher scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°c and 8°c: only specific lots are affected (mda/2017/034).
  • Action
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN) and that they understand the problem and the actions to be taken. Destroy all affected lots (listed in the FSN) and contact Thermo-Fisher customer services / local distributor for replacements. Discs that have been stored between -20°C and 2°C remain unaffected for the entire shelf life (36 months). If concerns exist after repeat testing, alternative methods of establishing ceftazidime susceptibility should be used. As part of your review processes, report any incorrect results to MHRA via Yellow Card or the relevant devolved administration.

Device

ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc

Manufacturer

Oxoid Ltd
  • Manufacturer Address
    Martyn Rogers Thermofisher Scientific Wade Road Basingstoke RG24 8PW Telephone: 01256 694 245martyn.rogers@thermofisher.com
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    MHRA