Events

Rappel de Device Recall Abbott Point of Care Inc

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
    71665
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2361-2015
  • Date de mise en oeuvre de l'événement
    2015-06-15
  • Date de publication de l'événement
    2015-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138625
  • 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
    Test, time, prothrombin - Product Code GJS
  • Cause
    Certain lots of pt/inr cartridges may generate a higher than typical number of pt/inr star outs potentially delaying the generation of patient results for pt/inr.
  • Action
    Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.

Device

Device Recall Abbott Point of Care Inc
  • Modèle / numéro de série
    All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
  • Description du dispositif
    i-Stat PT/INR Cartridges || List number 03P89-24 || The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. || a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
  • 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