Events

Retiro De Equipo (Recall) de Liquid Urine Control Level 3

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.

¿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
    77152
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2167-2017
  • Fecha de inicio del evento
    2017-04-27
  • Fecha de publicación del evento
    2017-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155040
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Causa
    According to randox laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of total protein (urine). the values for the mean of all instruments are incorrect by a factor of 10. instrument specific values are correct. this does not affect the performance or stability claims of the product. as control results will be outside of the quoted range this may result in a delay in reporting the sample test results. however as the correct instrument specific means are also included in the value sheet this delay is unlikely. customers have been referred to their medical director for further advice.
  • Acción
    Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.

Device

Liquid Urine Control Level 3
  • Modelo / Serial
    Catalogue number UC5075 Batch number 907UC
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
  • Descripción del producto
    Liquid Urine Control Level 3 || For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
  • Manufacturer
    Randox Laboratories

Manufacturer

Randox Laboratories
  • Dirección del fabricante
    Randox Laboratories, 515 Industrial Blvd, Kearneysville WV 25430-2778
  • Empresa matriz del fabricante (2017)
    Randox Holdings Limited
  • Source
    USFDA