Events

Retiro De Equipo (Recall) de Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2)

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
    80211
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2279-2018
  • Fecha de inicio del evento
    2018-05-22
  • Fecha de publicación del evento
    2018-06-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164878
  • 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
    The recalling firm has confirmed that free kappa light chains in liquid assayed specific protein controls increase over the shelf life of the product. this may lead to a delay in reporting free kappa light chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lambda chains.
  • Acción
    On May 22, 2018, Randox issued an Urgent Field Safety Notice to affected distributors along with an Important Notice and updated IFU. The letter advised customers of the product issue. It further instructed distributors to do the following: 1. Discuss the contents of the notice with your Medical Director. 2. Place a copy of the important notice and updated IFU into any remaining stock. 3. Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. If you have any questions after reviewing this information, you may contact the firm at technical.services@randox.com.

Device

Device Recall Randox Liquid Assayed Specific Protein Control Level 2 (SP Control 2)
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.
  • Descripción del producto
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
  • 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