Events

Rappel de DILUENT UNIVERSAL

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

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
    23128
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2015-02-18
  • 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
    This recall is related to a potential reduction in the signal of the elecsys cmv igm assay when used in combination with some specific lots of diluent universal which may lead to false negative results for patients samples with high reactivity against one specific antigen included in the assay. therefore patient samples having also a high reactivity against this specific antigen may be affected by reduced cut-off values which may lead to a false negative result when the affected combination is used. the signal reduction has only minor effects on the calibrators and controls.

Device

DILUENT UNIVERSAL
  • Modèle / numéro de série
    Model Catalog: 03183971122 (Lot serial: 176899); Model Catalog: 03183971122 (Lot serial: 175913); Model Catalog: 11732277122 (Lot serial: 175913); Model Catalog: 03183971122 (Lot serial: 178383); Model Catalog: 11732277122 (Lot serial: 178383); Model Catalog: 03183971122 (Lot serial: 178386); Model Catalog: 11732277122 (Lot serial: 178386); Model Catalog: 03183971122 (Lot serial: 180209); Model Catalog: 11732277122 (Lot serial: 183653); Model Catalog: 03183971122 (Lot serial: 183653); Model Catalog: 11732277122 (Lot serial: 176899); Model Catalog: 11732277122 (Lot serial: 176099); Model Catalog: 03183971122 (Lot serial: 176099); Model Catalog: 11732277122 (Lot serial: 183652); Model Catalog: 03183971122 (Lot serial: 183652); Model Catalog: 11732277122 (Lot serial: 180209); Model Catalog: 04784618190 (Lot serial: 182962); Model Catalog: 04784618190 (Lot serial: 179689)
  • Description du dispositif
    DILUENT UNIVERSAL
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Adresse du fabricant
    LAVAL
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    HC