Events

Rappel de UniCel DxH 600/800 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
    77145
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2158-2017
  • Date de mise en oeuvre de l'événement
    2017-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155030
  • 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
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
  • Action
    An Urgent Medical Device Recall letter dated 4/24/17 was sent to customers to inform them that there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. The letter informs the customers of the issue, impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at Http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the US and Canada, customers outside the U.S. and Canada are instructed to contact their local Beckman Coulter representative.

Device

UniCel DxH 600/800 Coulter Cellular Analysis System
  • Modèle / numéro de série
    all software versions
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
  • Description du dispositif
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
  • 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