Events

Rappel de Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

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 Corp..

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
    54768
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0893-2011
  • Date de mise en oeuvre de l'événement
    2010-03-31
  • Date de publication de l'événement
    2011-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89130
  • 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
    Upc Reader (bar code reader) - Product Code RFZ
  • Cause
    There is a mismatch between the class of the laser barcode scanner and the labeling of the hemochron signature elite: some of the devices were inadvertently equipped with class ii laser barcode scanner instead of the intended class i barcode scanner.
  • Action
    Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.

Device

Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System
  • Modèle / numéro de série
    Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
  • Description du dispositif
    Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Adresse du fabricant
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA