Events

Rappel de TRIAGE BNP ASSAY FOR BECKMAN COULTER INC. IMMUNOASSAY SYSTEMS

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

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
    44259
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-06
  • 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 issue is limited to a single lot of the product. in a portion of lot k328163 the bottle labeled as calibrator level 5 actually contains calibrator level 4. this results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected level 5 calibrator. although not all kits from this lot are impacted we cannot determine which specific calibrator level 5 bottles in this lot are affected. therefore it is recommended that customers stop using all product from this lot and discard any unused product.

Device

TRIAGE BNP ASSAY FOR BECKMAN COULTER INC. IMMUNOASSAY SYSTEMS
  • Modèle / numéro de série
    Model Catalog: 98202 (Lot serial: K328163)
  • Description du dispositif
    TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS
  • Manufacturer
    ALERE CANADA

Manufacturer

ALERE CANADA
  • Adresse du fabricant
    OTTAWA
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC