Events

Retiro De Equipo (Recall) de Randox Lipase (Colorimetric)

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 Randox Laboratories Ltd..

¿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
    75207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0123-2017
  • Fecha de inicio del evento
    2016-08-02
  • Fecha de publicación del evento
    2016-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149666
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Causa
    According to the firm carry over was observed when the lipase test is run directly before or after the ldl and triglycerides assays. customers are instructed to amend the running order for all instruments using these reagents to ensure lipase is not place directly before or after ldl or triglycerides. a correction was made to the ifu for the lipase assay and all customers who purchased the lipase kit in the usa were contacted with the updated instruction.
  • Acción
    Randex Laboratories sent an Urgent Field Safety Notice letter dated June 17, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the response section of this form technical.services@randox.com. For questions contact Randex Technical Service.

Device

Randox Lipase (Colorimetric)
  • Modelo / Serial
    Catalogue number:   LI3837, LI7979, LI8050, LI8361
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Randox Lipase (Colorimetric) || Product Usage: || A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
  • Manufacturer
    Randox Laboratories Ltd.

Manufacturer

Randox Laboratories Ltd.
  • Dirección del fabricante
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Empresa matriz del fabricante (2017)
    Randox Holdings Limited
  • Source
    USFDA