Events

Field Safety Notices about Combur-Test / Chemstrip / ChoiceLine 10 test

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
    We regret to inform you that we have identified an error in some languages in the method sheets of some urine test strips providing a test field for nitrite (nit). the error appears in the sections “limitations - interferences” or section / table “accuracy” in different language versions however not all languages are always affected. specifics germs which are clearly gram-negative are falsely classified as gram-positive. chemistry of strip measurement system is not affected. no risk of erroneous measurement is related. .

Device

Combur-Test / Chemstrip / ChoiceLine 10 test

Manufacturer

Roche Diagnostics