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 Abbott.

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 077 07 18 000
  • Date de mise en oeuvre de l'événement
    2018-07-12
  • 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=12913
  • 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
    Abbott has identified the following issues with the alinity ci‐series which may present a potential performance issue in alinity ci‐series software version 2.10. abbott is releasing alinity ci‐series software version 2.50 to correct these issues (see details in appendix a). 1. removing racks during the maintenance state is not detected by the system. issues with orders may occur when reloading a rack with samples and returning to running state. 2. orders created using more than one of the i‐series, c‐series, or calculated options to select assays will only include the assays selected in the last filtered view, if the order is saved prior to returning to the all option. 3. enabling an assay when the processing module is in the running or processing status causes the assay to be re‐installed. 4. a sample with 270 test orders remained in the scheduled status and would not process. 5. some maintenance and diagnostic procedures can appear to have completed successfully when there was insufficient inventory.

Device

Alinity ci‐series System Control Module (SCM)
  • Modèle / numéro de série
    List Number (LN): 03R70‐01
  • Description du dispositif
    Analyzers, Laboratory, Clinical Chemistry/Immunoassay
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Représentant du fabricant
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA