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 069 05 13 000
  • Date de mise en oeuvre de l'événement
    2013-05-20
  • 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=3624
  • 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
    An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present: 1. ih-1000 is in status "ready to start" and, 2. the user requests the unloading of a reagent rack while the system is creating the internal batch, the time slot during which the error could occur is about 2 seconds. 3. another rack is loaded immediately afterwards in the same position. if all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch. due to a software failure, the system may only use the vial placed in the first position of the re-ioaded rack for all the tests of the ongoing batch.

Device

IVDs, blood transfusion instrumentation , IH-1000
  • Modèle / numéro de série
    Cat.No.001000 SW version : All SN : see attached
  • Description du dispositif
    Fully Automated Blood Grouping Machine IH-1000
  • 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