Events

Rappel de Device Recall Beckman Coulter FP1000 Cell Preparation 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
    35778
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1466-06
  • Date de mise en oeuvre de l'événement
    2006-06-26
  • Date de publication de l'événement
    2006-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46858
  • 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
    cell preparation system - Product Code LXG
  • Cause
    During the cleaning cycle performed during the shutdown procedure of the beckman coulter fp1000 cell preparation system, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.
  • Action
    A Product Corrective Action letter was sent on June 26, 2006 informing users that during the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results. To reduce the risk of incorrect results from dripping fluid, users were advised to remove all patient samples, reagents, controls, and calibrators before initiating the shutdown cycle of the Beckman Coulter FP1000. Software will be modified in the next version to prevent the possibility of dripping bleach during the shutdown cycle. The Product Corrective Action letter is to be maintained as part of the customer''s laboratory Quality System documentation. The enclosed Response Form is to be completed and returned within 10 days to the recalling firm. Customers are also advised to contact the firm or their local Beckman Coulter Representative if there are questions.

Device

Device Recall Beckman Coulter FP1000 Cell Preparation System

Manufacturer

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