Events

Rappel de Device Recall Sysmex XE5000 Automated Hematology 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 Sysmex America, 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
    62580
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0255-2013
  • Date de mise en oeuvre de l'événement
    2012-06-01
  • Date de publication de l'événement
    2012-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113586
  • 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 variation of reticulocyte counts between xe series (xe-2100, xe-5000) and xt-series (xt-2000i, xt-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the xe-series because of a low bias.
  • Action
    Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate. Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.

Device

Device Recall Sysmex XE5000 Automated Hematology System
  • Modèle / numéro de série
    catalog #063-7591-7, all serial numbers
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including Puerto Rico.
  • Description du dispositif
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 || The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • Adresse du fabricant
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Société-mère du fabricant (2017)
    Sysmex Corp.
  • Source
    USFDA