Events

Field Safety Notices about cobas u

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 Diagnostics.

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
    With this notification we would like to inform you about the possible contamination of cuvettes of cobas u cuvette with small plastic particles. when used on cobas u 701 microscopy analyzer, these particles will be recognized as bacteria by the analyzer. hence, a false positive result for the parameter bacteria (bac) is the potential consequence. this can lead to wrong diagnosis of asymptomatic bacteriuria. in the worst case, a treatment decision can be made based on erroneous positive results for bacteria in urine. only lot 16483701 was reported as affected. roche diagnostics received one customer complaint regarding this issue. .

Device

cobas u

Manufacturer

Roche Diagnostics