Events

Rappel de Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i 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
    55173
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2590-2010
  • Date de mise en oeuvre de l'événement
    2010-02-25
  • Date de publication de l'événement
    2010-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90219
  • 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 on their unicel dxc clinical systems (880i, 860i,680i and 660i systems with serial number <2760 that have software version 4.9.01 installed and have the vme motorola ics board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
  • Action
    Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634

Device

Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems
  • Modèle / numéro de série
    Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
  • Description du dispositif
    UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software || version: 4.9.01 || The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA