Events

Rappel de Device Recall Unicel DxH 800 Coulter Cellular Analysis System

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
    55495
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1905-2010
  • Date de mise en oeuvre de l'événement
    2009-07-28
  • Date de publication de l'événement
    2010-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90993
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    The recall was initiated after beckman coulter confirmed an issue with the unicel dxh 800 during in-house testing. it was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. this situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.
  • Action
    Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States or contact your local Beckman Coulter Representative.

Device

Device Recall Unicel DxH 800 Coulter Cellular Analysis System
  • Modèle / numéro de série
    Serial Numbers: AN07020, AN05001, AN05004, AM44041, AN07015, AM51052, AN10031
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to: AZ, LA, IL, NY, PA & TN
  • Description du dispositif
    Unicel DxH 800 Coulter Cellular Analysis System, || Part number(s): 629029
  • 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