Events

Rappel de CHIRON RIBA HCV 3.0 STRIP IMMUNOBLOT ASSAY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GRIFOLS DIAGNOSTIC SOLUTIONS INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    23874
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-05-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Ortho clinical diagnostics recently became aware that some of the products that were recently shipped from their warehouse may have exceeded temperature specifications during transit. as a precaution customers are advised to immediately discontinue using and discard all affected product.

Device

CHIRON RIBA HCV 3.0 STRIP IMMUNOBLOT ASSAY
  • Modèle / numéro de série
    Model Catalog: 930600 (Lot serial: 108209); Model Catalog: 713180 (Lot serial: EB310A); Model Catalog: 930820 (Lot serial: EXE184); Model Catalog: 715280 (Lot serial: LAB148A); Model Catalog: 1924547 (Lot serial: 501902620942); Model Catalog: 725230 (Lot serial: FYB072D); Model Catalog: 8650939 (Lot serial: 0482); Model Catalog: 8445207 (Lot serial: 400505392406); Model Catalog: 715530 (Lot serial: PG162A); Model Catalog: 8046872 (Lot serial: 552200691409); Model Catalog: 6800190 (Lot serial: N9197); Model Catalog: 8392292 (Lot serial: 61404512378); Model Catalog: 1655281 (Lot serial: 621703922893); Model Catalog: 8257289 (Lot serial: 671201961843); Model Catalog: 716980 (Lot serial: RMG454A1); Model Catalog: 721830 (Lot serial: LS162A); Model Catalog: 721030 (Lot serial: LK178A); Model Catalog: 8478034 (Lot serial: 642801781184); Model Catalog: 1529387 (Lot serial: 596301721740); Model Catalog: 6800191 (Lot serial: P9198); Model Catalog: 114 2561 (Lot serial: 1030); Model Catalog: 110 7804 (Lot serial: 1030
  • Description du dispositif
    CHIRON RIBA HCV 3.0 STRIP IMMUNIBLOT ASSAY
  • Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Manufacturer

GRIFOLS DIAGNOSTIC SOLUTIONS INC.
  • Adresse du fabricant
    EMERYVILLE
  • Société-mère du fabricant (2017)
    Grifols Sa
  • Source
    HC