Events

Rappel de I-STAT 1 ANALYZER SYSTEM - PT/INR CARTRIDGE AND CONTROLS

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
    143475
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-29
  • 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
    Abbott point of care has determined that i-stat pt/inr cartridges have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr.

Device

I-STAT 1 ANALYZER SYSTEM - PT/INR CARTRIDGE AND CONTROLS
  • Modèle / numéro de série
    Model Catalog: 04J50-01 (Lot serial: R13149A); Model Catalog: 03P89-24 (Lot serial: R13149A); Model Catalog: 04J50-02 (Lot serial: R13149A); Model Catalog: 03P89-24 (Lot serial: R13151); Model Catalog: 04J50-01 (Lot serial: R13151); Model Catalog: 04J50-02 (Lot serial: R13151); Model Catalog: 03P89-24 (Lot serial: R13151A); Model Catalog: 04J50-01 (Lot serial: R13151A); Model Catalog: 04J50-02 (Lot serial: R13151A); Model Catalog: 03P89-24 (Lot serial: C13139 TO C13270A); Model Catalog: 04J50-02 (Lot serial: C13139 TO C13270A); Model Catalog: 04J50-01 (Lot serial: C13139 TO C13270A)
  • Description du dispositif
    I-STAT 1 ANALYZER SYSTEM - PT/INR CARTRIDGE AND CONTROLS
  • 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