Events

Rappel de Device Recall AQUIOS CL Flow Cytometer 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
    77997
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3135-2017
  • Date de mise en oeuvre de l'événement
    2017-08-21
  • 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=158468
  • 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
    Flow cytometric reagents and accessories. - Product Code OYE
  • Cause
    Beckman coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the sample prep probe of the aquios cl drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
  • Action
    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received electronically) at: Regulatory.Notifications@beckmancoulter.com -include in subject field: FA-31696 AQUIOS CL August 2017. If you have any questions regarding this notification, please contact: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 800-369-0333 in the United States and Canada. ¿ By email: LScustomerLetter@Beckman.com ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Device Recall AQUIOS CL Flow Cytometer System
  • Modèle / numéro de série
    All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
  • Description du dispositif
    AQUIOS CL Flow Cytometer System || The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
  • 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