Events

Retiro De Equipo (Recall) de Device Recall Access hLH Calibrators

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
    63784
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0572-2013
  • Fecha de inicio del evento
    2012-11-05
  • Fecha de publicación del evento
    2012-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114768
  • 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
    Radioimmunoassay, luteinizing hormone - Product Code CEP
  • Causa
    Beckman coulter inc. (bec) has demonstrated that real time stability testing of hlh calibrator of certain lots have failed the 13-month and 14-month time points. per bec's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. therefore, these lots did not meet bec's procedural requirements for a 12-month shelf-lif.
  • Acción
    Beckman Coulter Inc. (BEC) sent an "URGENT FIELD SAFETY NOTICE" dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these the affected lots did not meet BEC's procedural requirements for a 12-month shelf-life claim. Contact the firm at 952-448-4848 for assistance with this recall.

Device

Device Recall Access hLH Calibrators
  • Modelo / Serial
    Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Moldova Republic, Morocco, Myanmar, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe
  • Descripción del producto
    The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. || The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA