Events

Rappel de VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)

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
    24657
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • 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
    A reference standardization of the roche vancomycin assays was done by the manufacturer against the reference method. it was decided to correct both methods against the reference method. the cobas integra assay was corrected by a reagent modification. the instruction for use of the vancomycin assays already show a method comparison against cobas integra with the changed formulation which is not yet available on the market. this may lead to the assumption that both methods are comparable and may affect the interpretation of results. since the cobas integra reagent is not yet adapted results generated with cobas integra are still up to 20% higher than with cobas c or modular p systems.

Device

VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)
  • Modèle / numéro de série
    Model Catalog: 04642481190 (Lot serial: all); Model Catalog: 04642490190 (Lot serial: all); Model Catalog: 04491050190 (Lot serial: all)
  • Description du dispositif
    VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITAC;VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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