Events

Rappel de Access Immunoassay Systems Reaction Vessels

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
    66521
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0519-2014
  • Date de mise en oeuvre de l'événement
    2013-10-02
  • Date de publication de l'événement
    2013-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122543
  • 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
    Beckman coulter is initiating a recall for the access immunoassay systems reaction vessels, including the acess/access 2 immunoassay systems, syncron lxi 725 clinical system, and unicel dxc 600i synchron access clinical system because beckman coulter has observed an intermittent increase in access system "wash carousel motion errors" with specific lots of access system reaction vessels (rvs). i.
  • Action
    Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.

Device

Access Immunoassay Systems Reaction Vessels
  • Modèle / numéro de série
    Part Number 81901, Lot Numbers: 13181168-13341170.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
  • Description du dispositif
    Access Immunoassay Systems Reaction Vessels. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • 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