Field Safety Notices about Roche omni c, roche omni s, cobas b 221, b121 and b121

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by Roche Diagnostics GmbH.

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
    Field Safety Notice
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Roche Diagnostics GmbH an information about the omission in the instructions for use. Namely, the maximal life cycle of 52 weeks of reference electrodes on diagnostic systems Roche OMNI C, Roche OMNI S, cobas b 221, b121 and b121.
    The manufacturer has advise users to replace the referent electrode if it is older than 52 weeks and will provide a new version of software support including a reminder for electrode replacement. The complemented version of the instructions for use will be delivered to users.
    The safety information is available here and here.