Events

Field Safety Notices about cobas u 601 / cobas u 701

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
  • Date
    2017-12-21
  • 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 sample mismatch within one rack. the analyzer may not transport the rack correctly, so that tubes might be detected twice. as a consequence, the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack id. hence, a sample mismatch is possible between samples processed on the same rack, because the tubes are pipetted in the order given by the rack position and the test result assigned to the wrong sample id. the sample id read twice is thus listed in duplicate in the sample order list and test result list. the orders/test results have different rack ids. the consecutive sample id’s are also affected, since they are listed only once. as a consequence, they have an incorrect rack position displayed. .

Device

cobas u 601 / cobas u 701

Manufacturer

Roche Diagnostics