Events

Rappel de Device Recall Beckman Coulter Slidemaker Stainer

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
    77778
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3101-2017
  • Date de mise en oeuvre de l'événement
    2017-06-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157861
  • 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
    The firm has identified that a fitting in some slidemaker stainer units may not completely seal after installation.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated June 20, 2017. The notification advised consignees to immediately contact a Beckman Coulter representative if a leak is observed to schedule a service, to inspect reagent supply drawer for spills, and to follow best laboratory practices when using the device (including Personal Protective Equipment). Beckman Coulter indicates that the issue will be resolved with the replacement of the correct fitting on all impacted instruments. Labs were advised to notify all staff of the recall and to retain the notification. They were also instructed to forward the recall notice to all customers, if any product was further distributed, and to complete and return the Customer Response form within ten days of receiving the recall notification. Completed forms are to be sent back to the firm via email to Regulatory.Notifications@beckmancoulter.com. Regulatory Affairs Mail Code 31-B06. Questions can be directed to beckmancoulter.com or 800-526-7694. Consignees outside of the US are advised to contact their Beckman Coulter representative in the case that questions do arise.

Device

Device Recall Beckman Coulter Slidemaker Stainer
  • Modèle / numéro de série
    P/N A85371AA20; Catalog No. 775222
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
  • Description du dispositif
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. || The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. || Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
  • 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