Events

Retiro De Equipo (Recall) de Device Recall Active Renin IRMA Kit

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
    63140
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0016-2013
  • Fecha de inicio del evento
    2012-01-20
  • Fecha de publicación del evento
    2012-10-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112672
  • 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, angiotensin i and renin - Product Code CIB
  • Causa
    The recall was initiated because beckman coulter has confirmed that the active renin irma test kit may exhibit a decrease in stability of the coated tubes. as a result, quality control and patient sample results may be falsely elevated by up to 72%.
  • Acción
    Beckman Coulter sent an Urgent Production Correction letter dated January 10, 2012 to all their customers who purchased the Manual Immunoassay Active Renin IRMA Test Kit. The letter provides the customers with an explanation of the problem and actions to be taken. Customers were instructed to discontinue use and discard all remaining affected inventory. Customers were asked to complete and return the enclosed Response Form with in 10 days. Customers with questions contact Customer Service Support at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633.

Device

Device Recall Active Renin IRMA Kit
  • Modelo / Serial
    Lot # 110919D, 111017C, 111017D, 111114C, 111212C.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    Active Renin IRMA Kit, Part Number DSL25100 || Product Usage: || The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, MS/E1.NE.02, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA