Events

Rappel de EMIT II PLUS OPIATES ASSAY

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

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
    128475
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-08-19
  • 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
    Siemens investigation confirmed that the introduction of a new syva polyclonal antibody lot (g1) for use in the dimension urine opiates screen has resulted in an alteration of specificity for levallorphan levorphanol nalorphine and oxycodone at the 300 and 2000 ng/ml cutoff concentration. as a result in the change in sensitivity to the cross reactant the claims for these compounds are no longer accurate for either the 300 or 2000 ng/ml cutoff as stated within the instructions for use (ifu). further investigation confirmed that syva beckman coulter and advia chemistry opiate reagents are impacted as well due to a common raw material used in the assays.

Device

EMIT II PLUS OPIATES ASSAY
  • Modèle / numéro de série
    Model Catalog: 9B309UL (Lot serial: H5); Model Catalog: DF93A (Lot serial: FA6258); Model Catalog: DF93A (Lot serial: FA7069); Model Catalog: DF93A (Lot serial: GA6324); Model Catalog: DF93A (Lot serial: GB6275); Model Catalog: DF93A (Lot serial: GB7029); Model Catalog: DF93A (Lot serial: GC6160); Model Catalog: 9B309UL (Lot serial: H2); Model Catalog: 9B329UL (Lot serial: H2); Model Catalog: 9B309UL (Lot serial: H3); Model Catalog: K5093 (Lot serial: 16090BB); Model Catalog: K5093 (Lot serial: 16019BA); Model Catalog: K5093 (Lot serial: 15308BA); Model Catalog: K5093 (Lot serial: 15252AF); Model Catalog: K5093 (Lot serial: 15168BA); Model Catalog: K5093 (Lot serial: 15078BB); Model Catalog: 9B329UL (Lot serial: J2); Model Catalog: 9B309UL (Lot serial: J2); Model Catalog: 9B329UL (Lot serial: J1); Model Catalog: 9B309UL (Lot serial: J1); Model Catalog: 9B329UL (Lot serial: H6); Model Catalog: 9B309UL (Lot serial: H6); Model Catalog: 9B329UL (Lot serial: H5); Model Catalog: DF93A (Lot serial: EA6091); Model C
  • Description du dispositif
    EMIT II PLUS OPIATES ASSAY;DIMENSION CLINICAL CHEMISTRY SYSTEM - OPIATES (UOPI);DIMENSION VISTA SYSTEM - URINE OPIATES SCREEN
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC