Events

Rappel de Device Recall iSTAT EC8 cartridges

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
    54652
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1795-2010
  • Date de mise en oeuvre de l'événement
    2010-02-05
  • Date de publication de l'événement
    2010-06-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88900
  • 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
    Device, Hemocrit measuring - Product Code JPI
  • 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.
  • Action
    The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.

Device

Device Recall iSTAT EC8 cartridges
  • Modèle / numéro de série
    List # 06F04-01, 02
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; Oman; Panama; Paraguay; Peru; Poland; Portugal; Qatar; Russian Federation; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; Trinidad and Tobago; Turkey; United Arab Emirates; Uruguay; Yemen; Netherlands Antilles; Venezuela; Australia; Belgium; France; Germany; Italy; New Zealand; Spain; Sweden; and The Netherlands.
  • Description du dispositif
    i-STAT EC8+ cartridges || The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.
  • 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