Events

Rappel de Device Recall UniCel DxH 800 COULTER Cellular Analysis System; UniCel DxH SMS 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
    72773
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0432-2016
  • Date de mise en oeuvre de l'événement
    2015-12-01
  • Date de publication de l'événement
    2015-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142192
  • 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
    Beckman coulter is recalling the dxh 800 slidemaker stainer software version 3.0.2.0 and dxh 600 software version 1.1.1.0 because the software for the dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated December 1, 2015, to all affected customers to inform them that Beckman Coulter is recalling the the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because of the possibility of sample misidentificaton. Customers were informed that during internal testing, Beckman Coulter determined that the software for the DxH systems noted above allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. The issue does not occur for edits of released results or for test orders requested through host transmission. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Customer Support Center at www.beckmancoulter.com/customersupport/support or via phone (800) 526-7694 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-5321.

Device

Device Recall UniCel DxH 800 COULTER Cellular Analysis System; UniCel DxH SMS COULTER Cellular A...
  • Modèle / numéro de série
    all serial numbers Part Nos. 629029, B24465, B24802
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.
  • Description du dispositif
    UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 || The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
  • 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