Events

Rappel de Device Recall Hemocrhon Jr APTT Cuvettes

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 ITC-Nexus Dx.

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
    68659
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2088-2014
  • Date de mise en oeuvre de l'événement
    2014-06-20
  • Date de publication de l'événement
    2014-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128402
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Cause
    Test results may be erroneously elevated or report an out-of-range high (oor-h) error code in non heparinized blood samples.
  • Action
    ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: Techsupport@itcmed.com Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.

Device

Device Recall Hemocrhon Jr APTT Cuvettes
  • Modèle / numéro de série
    Lot Number A4JCA001
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
  • Description du dispositif
    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
  • Manufacturer
    ITC-Nexus Dx

Manufacturer

ITC-Nexus Dx