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 Medion Grifols Diagnostics AG.

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 12 11 000
  • Date de mise en oeuvre de l'événement
    2011-12-20
  • 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=5&rid=1181
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Identified that cell #5 (donor m2683cg) of the affected products was supposedly wrongly identified as fyb negative. at release time medion's qc testings showed negative reactions with several anti-fyb reagents. additional testing performed later at medion, however, revealed that the serological reactivity from this donor varied from weak positive results to negative results depending on the commercial anti-fyb reagent used. the probable phenotype was fya/fyb weak (also known as fyx).

Device

Antibody identification cell panel kit
  • Modèle / numéro de série
    Ref. 213587: 610011010 (exp. 2011-11-12); Ref. 213392: 612011010 (exp. 2011-11-12); Ref. 213641: 612011010 (exp. 2011-11-12)
  • Description du dispositif
    Data-Cyte Plus 0.8%, Data-Cyte Plus 3% ,Data-Cyte Plus 3% US
  • Manufacturer
    Medion Grifols Diagnostics AG

Manufacturer

Medion Grifols Diagnostics AG
  • Société-mère du fabricant (2017)
    Grifols Sa
  • Source
    SFDA