Events

Retiro De Equipo (Recall) de Device Recall Rubella IgG EIA test kit

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 Bio-Rad 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
    49449
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0908-2010
  • Fecha de inicio del evento
    2008-08-20
  • Fecha de publicación del evento
    2010-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73408
  • 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
    enzyme linked immunoabsorbent assay, rubella - Product Code LFX
  • Causa
    Elevated optical density (od) values with the kit negative control.
  • Acción
    An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.

Device

Device Recall Rubella IgG EIA test kit
  • Modelo / Serial
    Lot F1108
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
  • Descripción del producto
    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 || For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Dirección del fabricante
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA