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 Bio-Rad Medical Diagnostics.

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 063 07 17 000
  • Date de mise en oeuvre de l'événement
    2017-07-17
  • 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=11308
  • 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
    It has come to our notice that for product id-papain, mal n° 005510, shows double population reactions when the auto-control is performed in papain one stage technique. it has been observed internally that in the last two weeks before expiry, the lots of papain mentioned above may not destroy these antigens as expected. there is no patient risk associated with this issue. the use of id-papain for compatibility testing and for the detection of antigens normally detected in the id-papain test is not impacted by this phenomenon and the papain can be used for this purpose.

Device

ID-Papain
  • Modèle / numéro de série
    Double population reaction Mat. n° : 005510 Loss of enzyme activity Mat. n° : 005510 Lot No IHD : 06311 961, 06311 97 1, 06311 991, 06311 02 1 Lot No SAP : 121302961, 124782971, 141517991, 145832021 Expiry Date : 03.07.2017, 17.07.2017, 31.07.2017, 14.08.2017
  • Description du dispositif
    Immunohematology, ID-Papain
  • Manufacturer
    Bio-Rad Medical Diagnostics

Manufacturer

Bio-Rad Medical Diagnostics