Events

Field Safety Notices about cobas b 221

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Roche.

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 Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Internal studies revealed a software issue which affects the urea sample measurement results. the urea recovery for samples and qc measurement results can be both, too low or too high. all customers using any lot of mss cassettes glu/lac/urea(bun) to test for urea on the cobas b 221 <6> instrument are affected. to avoid any risk of reporting wrong patient sample results for the urea parameter, sample measurements have to be measured two times until this issue is fixed in an upcoming software version, planned for january 2017. .

Device

cobas b 221
  • Model / Serial
  • Manufacturer
    Roche

Manufacturer

Roche