Events

Rappel de I-STAT 1 ANALYZER SYSTEM - CTNI CARTRIDGE CONTROLS AND CALIBRATORS

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
    103529
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-01-05
  • 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
    It was found that there was a higher than expected rate of values from control level 1 and calibration verification level 1 that were outside of the value assignment sheet (vas) limits. internal studies have determined that the presence of co2 in the head space of the vial is the cause of high results. venting the gas in the head space of the vial to remove any co2 that may be present prior to the thawing of the material has been shown to prevent the occurrence of high results.

Device

I-STAT 1 ANALYZER SYSTEM - CTNI CARTRIDGE CONTROLS AND CALIBRATORS
  • Modèle / numéro de série
    Model Catalog: 06F14-02 (Lot serial: M102083); Model Catalog: 06F13-02 (Lot serial: M102081); Model Catalog: 06F15-02 (Lot serial: M10208); Model Catalog: 06F14-02 (Lot serial: M10208); Model Catalog: 06F13-02 (Lot serial: M10208); Model Catalog: 06F12-02 (Lot serial: M10208); Model Catalog: 06F15-02 (Lot serial: M102083); Model Catalog: 06F12-02 (Lot serial: M102081); Model Catalog: 06F13-02 (Lot serial: M102083); Model Catalog: 06F12-02 (Lot serial: M102083); Model Catalog: 06F15-02 (Lot serial: M102082); Model Catalog: 06F14-02 (Lot serial: M102082); Model Catalog: 06F13-02 (Lot serial: M102082); Model Catalog: 06F12-02 (Lot serial: M102082); Model Catalog: 06F15-02 (Lot serial: M102081); Model Catalog: 06F14-02 (Lot serial: M102081)
  • Description du dispositif
    I-STAT CARDIAC MARKER CONTROL LEVELS 123 AND CALIBRATION VERIFICATION
  • 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