Events

Rappel de UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems

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 Beckman Coulter Inc..

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
    74569
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2272-2016
  • Date de mise en oeuvre de l'événement
    2014-04-22
  • Date de publication de l'événement
    2016-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147928
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Possible leaking of no foam solution from the no foam bottle assembly on the unicel dxc synchron systems.
  • Action
    An Important Product Notice dated 4/22/14 was sent to all their customers to inform them that Beckman Coulter has identified a manufacturing issue with a plastic fitting on the No Foam Bottle Assembly which may crack and cause No Foam solution to leak. The letter informs the customers of the impact, action to be taken, and resolution. Customers are asked to inspect the No Foam Bottle Assembly for leaks prior to refilling the bottle. If leaks occur, customers should contact Customer Support Center following the instructions provided. Customers are instructed to complete the enclosed response form within 10 days. Customers with questions are instructed to contact the firm's Customer Support Center - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada, contact your local Beckman Coulter Representative.

Device

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
  • Modèle / numéro de série
    Up to and including 6133
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.
  • Description du dispositif
    UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems || The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. || Catalog No. || UniCel DxC 800 Synchron Clinical Systems || UniCel DxC 600 Synchron Clinical Systems || UniCel DxC 600i Synchron Access Integrated Clinical Systems || UniCel DxC 880i Synchron Access Integrated Clinical Systems || UniCel DxC 660i Synchron Access Integrated Clinical Systems || Product Labeling Reference No. A93719 || For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA