Retiro De Equipo (Recall) de Device Recall Phenol: Chloroform:Isoamyl Alcohol

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 Promega Corpopration.

¿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
    49586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0483-2009
  • Fecha de inicio del evento
    2008-06-04
  • Fecha de publicación del evento
    2008-12-15
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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 LTD
  • Causa
    Promega corporation received reports of leaking bottles of phenol:chloroform:isoamyl alcohol (part # z5112), a component of the rnagents¿ total rna isolation system (catalog # z5110). promega product z5112 is a mixture of phenol, chloroform and isoamyl alcohol. if phenol contacts skin, it can cause burns and poisoning. the fumes of this product are also harmful.
  • Acción
    Consignees were sent a "Promega Urgent Product Alert-Risk of Injury" letter dated June 9, 2008. The letter described the product, problem and provided instructions on handling, inspection and disposition of product. In addition, E-mail notifications were sent to distributors and branch offices on May 29,2008. For questions and additional information, contact your local Promega representative or Promega Technical Service at 800-356-9526 and press "4", or e-mail at techserv@promega.com.

Device

  • Modelo / Serial
    Lot Codes: 237809 and 248195.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA including states of IN, ME, NE, NY, WI, PA, NC, FL, OR, UT, MI, IL, AL, OR, GA, CA, MD, TX, MA, UT, MO, OH, and LA, and countries of Canada, Mexico, Brasil, China, Japan, Germany, Singapore, Great Britain, Australia and France.
  • Descripción del producto
    RNAgents¿ Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. || Bottle Label: || Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents¿ Total RNA Isolation System. || The RNAgents¿ Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Promega Corpopration, 2800 Woods Hollow Rd, Madison WI 53711-5300
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA