Events

Rappel de I-STAT 1 ANALYZER SYSTEM - CHEM8+ 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
    61990
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2010-03-18
  • 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 has determined that there is a dependence of the i-stat hct assay on the vertical pitch angle of the i-stat analyzer during the blood analysis cycle. it is related to the tendency of its red blood cells to sediment in the i-stat sample holding chamber while awaiting analysis. internal testing has demonstrated that the other analytes reported by these products do not have a dependency on the vertical pitch angle of the i-stat analyzer. it was decided to update the i-stat hematocrit/hct and calculated hemoglobin/hb cartridge and test information sheet to ensure the performance of the product.

Device

I-STAT 1 ANALYZER SYSTEM - CHEM8+ CARTRIDGE AND CONTROLS
  • Modèle / numéro de série
    Model Catalog: 03M88-02 (Lot serial: ); Model Catalog: 06F05-01 (Lot serial: ); Model Catalog: 06F01-02 (Lot serial: ); Model Catalog: 06F08-01 (Lot serial: ); Model Catalog: 06F08-02 (Lot serial: ); Model Catalog: 06F04-01 (Lot serial: ); Model Catalog: 06F04-02 (Lot serial: ); Model Catalog: 03M88-01 (Lot serial: ); Model Catalog: 06F02-02 (Lot serial: ); Model Catalog: 06F02-01 (Lot serial: ); Model Catalog: 06F07-02 (Lot serial: ); Model Catalog: 06F07-01 (Lot serial: ); Model Catalog: 06F01-01 (Lot serial: ); Model Catalog: 06F05-02 (Lot serial: ); Model Catalog: 03M86-01 (Lot serial: ); Model Catalog: 03M86-02 (Lot serial: )
  • Description du dispositif
    I-STAT 1 ANALYZER SYSTEM-CHEM8+ CARTRIDGE
  • 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