Events

Rappel de Device Recall Beckman Unicel DxC 600 and DxC 800 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
    55276
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2633-2011
  • Date de mise en oeuvre de l'événement
    2009-07-23
  • Date de publication de l'événement
    2011-06-23
  • 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=90458
  • 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
    The recall was initiated because the wash concentrate tube assembly 142 may fail to deliver the appropriate amount of wash concentrate on some synchron dxc systems due to an accumulation of crystals. the impact of this issue would include: (1) quality control and patient results can potentially be affected. (2) if system has been calibrating properly and quality control is recovering within es.
  • Action
    Beckman Coulter sent out an "Urgent Product Corrective Action" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions: " If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada. " This issue will be corrected with an upcoming software version and tubing modification. " Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records. Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.

Device

Device Recall Beckman Unicel DxC 600 and DxC 800 Clinical Systems
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Canada
  • Description du dispositif
    Tubing Assembly #142, V2, V12 Mixer/Wash a component of || the DxC instruments. || Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC 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