Events

Retiro De Equipo (Recall) de Device Recall COULTER GENS

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
    57990
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1956-2011
  • Fecha de inicio del evento
    2011-01-31
  • Fecha de publicación del evento
    2011-04-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97925
  • 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
    Counter, differential cell - Product Code GKL
  • Causa
    This recall was initiated because beckman coulter identified a problem with some date fields that are transmitted to the laboratory information system (lis). starting jan 1, 2011, the date fields will transmit as a blank field to the lis if the year is greater than 2010. the following dates are affected: run date, control expiration date, date of birth (for individuals born in 2011 or later), a.
  • Acción
    The firm, Beckman Coulter, sent an "URGENT: PRODUCTION CORRECTION" letter dated January 31, 2011 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Coulter LH 750 Analyzer, Coulter LH 780 Analyzer, Coulter LH 500 Series System, and Coulter GEN S System. The letter describes the product, problem and actions to be taken. The customers were instructed to work with their US vendor to assess how this affects their laboratory. The actions they choose are dependent on the configuration of their LIS. ACTION FOR ISSUE 1: Use Sample Drawn Date and Date of Birth information available at your LIS in lieu of the analyzer transmitted fields BIRTH and UDATE. Use the current date when the results are received at the LIS in lieu of the transmitted Run Date [DATE]. Print results from the Workstation to keep a copy of the analysis date on the analyzer, if necessary. Use the control expiration date from the analyzer display or printout. ACTION FOR ISSUE 2: If you use the LIS 1G1 transmission format, use the General Information group field names in place of the Retic Parameter group field names to identify each reticulocyte run (see Table in Issue 2 section). Check with your LIS vendor to determine if it is possible to switch to the LH 750 Workstation transmission format. Format requirements are LIS driver specific. For patients with Dates of Birth in 2011 for both Issue 1 and Issue 2, results should be reviewed to determine if decision rules or age-related limits sets were triggered inappropriately. RESOLUTION These issues will be corrected in a future software release for the LH Series products. The GEN¿¿S product has been discontinued; no software revisions will be forthcoming for the GEN¿¿S product line. Customers were also instructed to complete and return the PRODUCT CORRECTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 310B06, 11

Device

Device Recall COULTER GENS
  • Modelo / Serial
    part number: 6605381, 6605381R, 6605381U
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Monaco, Morrocco, Myanmar, Namibia, Netherlands, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Virgin Islands (US).
  • Descripción del producto
    Coulter GEN's || The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
  • 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