Events

Rappel de iSTAT G3 Cartridge

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
    56637
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1621-2011
  • Date de publication de l'événement
    2011-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94168
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    Certain lots of g3+ cartridges may be difficult to fill.
  • Action
    The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers. If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.

Device

iSTAT G3 Cartridge
  • Modèle / numéro de série
    Catalog number: 06F03-1, 06F03-02; Lot numbers: J06072, Exp 10/28/2006; J06076, Exp 11/14/2006; J06081, Exp 11/14/2006; J06083, Exp 11/14/2006; J06085, Exp 11/14/2006.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and country of : Canada.
  • Description du dispositif
    i-STAT G3+ Cartridge: PCO2 || Abbott Point of Care, || Princeton, NJ 08540 || The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
  • 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