Events

Rappel de UniCel DxC 600 PRO

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
    45960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1099-2008
  • Date de mise en oeuvre de l'événement
    2007-04-05
  • Date de publication de l'événement
    2008-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66586
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Cause
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Action
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.

Device

UniCel DxC 600 PRO
  • Modèle / numéro de série
    Part Number A10400. All serial numbers. All software versions.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Canada.
  • Description du dispositif
    UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA