Events

Avis De Sécurité sur COBAS TaqScreen MPX Test, version 2.0

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2013-11-18
  • Date de publication de l'événement
    2014-03-01
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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