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 BD.

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 078 10 18 001
  • Date de mise en oeuvre de l'événement
    2018-11-06
  • 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=13453
  • 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 , FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Bd has confirmed that a limited number of bd max™ systems were manufactured with purchased optical filters that have shown a potential to produce a false positive result for candida glabrata when processing samples positive for trichomonas vaginalis during testing with the bd max™ vaginal panel. if the bd max vaginal panel was successfully verified/validated using the contrived zeptometrix vaginal panel control panel, the risk of reporting a clinical false positive c.Glabrata result is low. the reported c. glabrata false positive results were all identified by customers when using the control material.

Device

BD MAX System
  • Modèle / numéro de série
    Catalog No.: 441916 Multiple serial numbers of the affected device are provided in the attached FSN. ................................................................. FDA update codes: BD Max Instrument, Catalog Number 441916 441927 Serial Numbers: CTI1201-CTI1288 Catalog Number 8090369/443364, 44336409 Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927
  • Description du dispositif
    IVD Test Reagent/Kits
  • Manufacturer
    BD

Manufacturer

BD