Safety Alert Or Field Safety Notices for Home use and Point of Care blood glucose monitoring system

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 Roche Diabetes Care.

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
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    The manufacturer issued a Field Safety Notice in May 2018.Roche has confirmed that only the identified lots are affected by this issue.
  • Reason
    Affected test strips, manufactured by roche diabetes care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.


  • Manufacturer Address
    Local Regulatory and Safety Officer Roche Diabetes Care Ltd Charles Avenue Burgess Hill West Sussex RH15 9RYTel:
  • Manufacturer Parent Company (2017)
  • Source