Events

Field Safety Notices about cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)

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
    Roche diagnostics received complaints from two customers that un-spun samples were incorrectly identified as “spun” by the spin status detection on cobas p 512 (64x) pre-analytical system. when non-centrifuged samples incorrectly identified as “spun” are further analyzed, erroneous results may occur and relevant medical risk cannot be entirely excluded. this case made us aware that we need to provide a better specification on the intended use of the spin status detection. the cobas p 512 (64x) and the cobas p 612 (63x) systems are not designed to make a sorting decision based on the spin status detection functionality. while investigating these complaints, we identified that all documentation related to .

Device

cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)
  • Model / Serial
    All cobas p 512 (64x) pre-analytical system All cobas p 612 (63x) pre-analytical system
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics