Events

Field Safety Notices about Tina-quant Roche/Hitachi, cobas c111

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Roche Diagnostics GmbH.

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
    2015-04-20
  • Event Date Posted
    2015-06-29
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2015/06/29/vazno-obavestenje-o-medicinskom-sredstvu-d-di2-tina-quant-rochehitachi-i-d-di2-cobas-c111/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Roche received a report of a patient case related to different results with coasys plus c and stago d-dimer for d-dimer gen. 2 test ". there was an overestimation of the measured value of the sample on the coasys plus c system, which led to false positives for the d-dimer. this problem is sample specific. immunoglobulins ("igm") interfere with "d-dimer gen. 2 "reagent, resulting in false elevated d-dimer results. the presence of immunoglobulins was demonstrated by immuno-adsorption chromatography, which showed that falsely elevated results were eliminated when immunoglobulins were removed from the sample in this way.

Device

Tina-quant Roche/Hitachi, cobas c111

Manufacturer

Roche Diagnostics GmbH