Events

Rappel de HemosIL von Willebrand Factor Activity Assay kit

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 Instrumentation Laboratory Co..

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
    61522
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1519-2012
  • Date de mise en oeuvre de l'événement
    2012-04-11
  • Date de publication de l'événement
    2012-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108339
  • 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, qualitative and quantitative factor deficiency - Product Code GGP
  • Cause
    Falsely elevated levels may be reported with the hemosil von willebrand factor activity assay.
  • Action
    Instrumentation Laboratories mailed Recall Letter via USPS to US and Canadian customers on April 11, 2012, through Beckman Coulter. The customer mailing and tracking of the Urgent Recall Notification and Recovery Procedure in the United States and Canada will be handled through the distributor, Beckman Coulter. Accounts are requested to check inventory for the product lots of Hemosll von Willebrand Factor Activity, PN 0020004700, listed in the table and document their destruction on the provided tracking form and return the completed form. Questions or concerns regarding this notification, please call Beckman Coulter Technical Service at (800) 526-7694. On March 29, an e-mail communication was circulated to the IL Affiliates in Europe and Japan requesting them to translate the Urgent Field Safety Notification [title of document outside US and Canada] and product destruction tracking form, mail the notification to their customer base and notify their Competent Authorities.. Fpr questions regarding this recall call 781-861-4467.

Device

HemosIL von Willebrand Factor Activity Assay kit
  • Modèle / numéro de série
    Lot Numbers:  B01424 Exp Date: March 31 , 2012; B11498 Exp Date: July, 31 , 2012; B11655 Exp Date: November 30, 2012; B11687 Exp Date: January 31 , 2013
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS BELGIUM, BRAZIL, CHILE, CHINA, CZECH REPUBLIC, DENMARK FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF KUWAIT LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, and the UNITED ARAB EMIRATES
  • Description du dispositif
    Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit || Part Number: 0020004700 || The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Adresse du fabricant
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA