Events

Rappel de Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

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
    56114
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2110-2010
  • Date de mise en oeuvre de l'événement
    2010-06-24
  • Date de publication de l'événement
    2010-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92693
  • 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
    assay, heparin - Product Code KFF
  • Cause
    An ingredient in the rqchrt whole blood controls for use with hemochron kaolin and celite hrt test tubes may become less potent over time and result in excessive high lqc failures.
  • Action
    ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.

Device

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST
  • Modèle / numéro de série
    Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
  • Description du dispositif
    RQCHRT HRT Control Level 1 & 2; || Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. || 20 vials Whole Blood - 2.0mL; dried || 20 vials Diluent - 4.0 mL || The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
  • 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