Events

Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Beckman Coulter Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57779
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2075-2011
  • Fecha de inicio del evento
    2010-10-22
  • Fecha de publicación del evento
    2011-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98085
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrode, ion specific, potassium - Product Code CEM
  • Causa
    This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
  • Acción
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.

Device

Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A64871  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 660i || The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA