Events

Retiro De Equipo (Recall) de NucliSENS Lysis Buffer

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 BioMerieux SA.

¿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
    78387
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0086-2018
  • Fecha de inicio del evento
    2017-10-18
  • 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=159394
  • 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
    General purpose reagent - Product Code PPM
  • Causa
    Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (dbs) samples. this can potentially cause the inhibition of pcr reactions and result in an uninterpretable test result. if using an internal control (ic) in the extraction process the ic could potentially be inhibited as well and invalidate test results.
  • Acción
    US customers were notified on 10/18/2017 via letter using 2-day Fed Ex shipment. Instructions included notifying all appropriate personnel in the laboratory or to customers if product was further distributed, refrain from using the affected product, and arrange for replacement of affected product by completing and returning the response form. It also instructed customers to contact and discuss any concerns regarding previously reported results with the appropriate Laboratory Medical Director to determine an appropriate course of action.

Device

NucliSENS Lysis Buffer
  • Modelo / Serial
    REF 200292, Lot 17022802, Exp Date 01/28/2019  Extended lot for RES 76675
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed domestically to MD, CO, and OH.
  • Descripción del producto
    NucliSENS Lysis Buffer || Extended lot for RES 76675
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Dirección del fabricante
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA