Events

Rappel de Integrated Data Management System Version 7.1, 7.2 and 7.3;

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 International Technidyne Corporation.

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
    55427
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2438-2010
  • Date de mise en oeuvre de l'événement
    2010-04-09
  • Date de publication de l'événement
    2010-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90826
  • 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
    A tabulation error in the integrated data management systems (idms) data management software that results in incorrect electronic quality control (eqc) summary reports: the operator and the device performance summary reports. the idms software is not used for the clinical management of individual patients.
  • Action
    ITC sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 10, 2010 to Distributors and First Consignee End Users identifying the affected product and affected summary reports, the reason for recall, and the actions to be taken by the distributors and customers. New Errata Instructions were enclosed with each letter and are to be put in the idms user guide for reference. The new instructions are to be followed when running reports for the ESV or TVT tests run by the Hemochron Response. The enclosed Customer Account Tracking Form is to be completed and returned to ITC indicating that the letter has been received and appropriate questions answered as to the use of the software system. Distributors are asked to check inventory for recalled product. If affected product is found, shipment should be stopped and placed on hold. Distributors should notify customers of the correction and provide them with a copy of the correction letter and updated instructions. This should be done by traceable mail. Distributors should return the account tracking form and return affected software disks for replacement. Questions should be directed to ITC Technical Support at 800-631-5945.

Device

Integrated Data Management System Version 7.1, 7.2 and 7.3;
  • Modèle / numéro de série
    Product code 464100, Version numbers 7.1.0, 7.2.0 and 7.3.0.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA, TN , TX, UT, VA, WA, and WI, and the countries of Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand.
  • Description du dispositif
    Integrated Data Management System - Version 7.1, 7.2 and 7.3; || ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Adresse du fabricant
    International Technidyne Corporation, 23 Nevsky St, Edison NJ 08820-2425
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA