Events

Field Safety Notices about COBAS TaqScreen MPX Test, version 2.0

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia 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
    2013-11-18
  • Event Date Posted
    2014-03-01
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/01/03/vazno-obavestenje-o-medicinskom-sredstvu-cobas-taqscreen-mpx-test-version-2-0-infektivna-imunologija-reagens/
  • 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
    The software incorrectly marks the reactive samples as inactive in the presence of curve peaks, instead of declaring the results invalid or correctly marking them as reactive. false non-reactive results can occur from 1 in 26.25 million tests to 1 in 4.09 billion tests. hcv infection can lead to serious adverse events or death if left untreated. however, this only happens in chronic carriers. the possibility of getting hcv infection due to the cobas taqscreen mpx test error, v2.0 is very weak. the curve peaks were also tested for cobas with taqscreen test, v2.0 in channel 2 (hbv), and to a lesser extent in channel 1 (hiv) with data from the european blood bank. in this regard, the possibility of false non-reactive results in channel 1 and 2 cobas with taqscreen mpx test, v 2.0 due to the appearance of peaks on the growth curve is extremely small.

Device

COBAS TaqScreen MPX Test, version 2.0

Manufacturer

Roche Diagnostics