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 Diagnostica Stago.

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 056 11 18 000
  • Date de mise en oeuvre de l'événement
    2018-11-20
  • 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=13504
  • 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
    Stago has informed that several customers have reported shortened (t1-t2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds for sta-control la2 have been observed (this range is specified on the kit value sheet). the subsequent root cause investigations have found that the issue is due to a sensitivity decrease which occurs towards the end of the respective lot number's shelf life. we have found this to be related to the material used for manufacturing the stoppers used only for the buffer and solvent vials. according to guidelines of the isth ssc anti phospholipids syndrome, several tests should be performed to detect and confirm the presence of la. hence, previously released patient results should not need to be re-assessed. there have been no reports of injury in relation to this issue.

Device

STACLOT LA (REF. 00600).
  • Modèle / numéro de série
    Lot Number: 251918 Expiry: 31 March 2019 Lot Number: 252751 Expiry: 30 September 2019
  • Description du dispositif
    An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago
  • Société-mère du fabricant (2017)
    Stago International
  • Représentant du fabricant
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA