Events

Alerte De Sécurité sur cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-04-18
  • Date de publication de l'événement
    2016-04-18
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418c.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: roche diagnostics cobas egfr mutation test, v2 ce- ivd and cobas cfdna sample preparation kit medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning its cobas egfr mutation test, v2 ce- ivd and cobas cfdna sample preparation kit. according to the manufacturer, several mutations (l858r, exon 19 deletion, t790m) inconsistently generated “no mutation detected” (i.E. false negative) results with the cobas egfr mutation test, v2 when utilising the cobas cfdna sample preparation kit during internal studies using contrived plasma specimens. there is no impact when using the cobas dna sample preparation kit with the cobas egfr mutation test, v2 to test formalin-fixed paraffin-embedded tumour (ffpet) tissue samples. patients with a false negative result for the mutations may be denied the prospect of prolongation of disease control and survival (8-12 months). the manufacturer will update the instructions for use (ifu) for the cobas egfr mutation test, v2 and cobas cfdna sample preparation kit to revise the handling of the eluate for plasma specimens prior to amplification and detection. users are advised to follow the revised instruction until the updated ifu become available. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2016.

Device

cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Diagnostics cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics