Events

Retiro De Equipo (Recall) de Device Recall Rabbit Kidney Culture

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 Diagnostic Hybrids Inc.

¿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
    53702
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0822-2010
  • Fecha de inicio del evento
    2009-01-21
  • Fecha de publicación del evento
    2010-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86385
  • 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
    Cells, animal and human, cultured - Product Code KIR
  • Causa
    During qc post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).
  • Acción
    Diagnostic Hybrids issued a "Product Notification" letter dated January 23, 2009 in addition to verbal communication of the affected product beginning January 21, 2009. The firm requested that all affected product be discarded /destroyed and not use for diagnostic testing. Consignees were asked to complete and return a Fax-Back form. For further information, contact Diagnostic Hybrids Technical Services at 1-866-344-3477 or 1-740-589-3300.

Device

Device Recall Rabbit Kidney Culture
  • Modelo / Serial
    Catalog Number: 48-0600, Lot #480109.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (CA, FL, GA, MA, MO, NY, NJ, TN, TX and VA), Ontario Canada and Manitoba Canada.
  • Descripción del producto
    Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each. || Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents.
  • Manufacturer
    Diagnostic Hybrids Inc

Manufacturer

Diagnostic Hybrids Inc
  • Dirección del fabricante
    Diagnostic Hybrids Inc, 1055 East State Street, Suite 100, Athens OH 45701-1526
  • Empresa matriz del fabricante (2017)
    Quidel Corporation
  • Source
    USFDA