Events

Rappel de AXSYM TROPONIN-I REAGENT PACK

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

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
    14991
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    1999-10-12
  • 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
    Calibration failures caused by error code 1027 "calibration check failure cal f/a ratio too small".

Device

AXSYM TROPONIN-I REAGENT PACK
  • Modèle / numéro de série
    Model Catalog: 3C29-20 (Lot serial: 54887M101 54889M100); Model Catalog: 3C29-20 (Lot serial: 54886M101 54887M100); Model Catalog: 3C29-20 (Lot serial: 54885M101 54886M100); Model Catalog: 3C29-20 (Lot serial: 54860M101 54885M100); Model Catalog: 3C29-20 (Lot serial: 53879M200 54860M100); Model Catalog: 3C29-20 (Lot serial: 53577M100 53577M101); Model Catalog: 3C29-20 (Lot serial: 53448M100 53448M101); Model Catalog: 3C29-20 (Lot serial: 53446M100 53446M101); Model Catalog: 3C29-20 (Lot serial: 53053M200 TO 53053M202); Model Catalog: 3C29-20 (Lot serial: 52735M300 523735M301); Model Catalog: 3C29-20 (Lot serial: 55153M201); Model Catalog: 3C29-20 (Lot serial: 54889M101 55153M200)
  • Description du dispositif
    AXSYM TROPONIN
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Adresse du fabricant
    MISSISSAUGA
  • 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