Events

Rappel de Electronic Data Interchange

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Abbott Point of Care Inc..

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
    53483
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0865-2010
  • Date de publication de l'événement
    2010-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85597
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Calculator/data processing module for clinical use - Product Code JQP
  • Cause
    Abbott point of care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the cds test record only.
  • Action
    Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.

Device

Electronic Data Interchange
  • Modèle / numéro de série
    i-STAT Catalog number: 111610 Abbott list number (US and Canada) 08K4501
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.
  • Description du dispositif
    i-STAT HL7 Interface || The HL7 Interface product is an accessory to the analyzer
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • Adresse du fabricant
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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
    USFDA