Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par DiaMed GmbH.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 068 06 13 000
  • Date de mise en oeuvre de l'événement
    2013-06-16
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3751
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1 000 may be observed. after deep investigations, confirm that in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation . 2. this negative result is consistent with the global interpretation of the test. 3. the system is configured without the second reading function activated for all tests results.

Device

IVDs,blood transfusion instrumentation, IH-1000
  • Modèle / numéro de série
    Product name: IH-1000 Product REF: 001000 IH-1000 software version: All version
  • Description du dispositif
    IVDs, blood transfusion instrumentation
  • Manufacturer
    DiaMed GmbH

Manufacturer

DiaMed GmbH
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Représentant du fabricant
    Al Nahir Trading co , Riyadh , (011)4770444
  • Source
    SFDA