Retiro De Equipo (Recall) de Device Recall Paraffin Wax

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 Richard-Allan Scientific Company.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Apparatus, melting point, paraffin - Product Code IDT
  • Causa
    Multiple complaints were received from customers indicating that they ordered product 8335(type 3 paraffin) but when they opened the box, they found product 8336 (type 6 paraffin) inside.
  • Acción
    ThermoFisher sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 15, 2016, to all affected customers. The letter contained the following instructions: If you have the above lot in your possession, please determine whether the bags are labeled as Type 3 (PN 8335) or Type 6 (PN 8336). ¿ If the product is labeled as Type 3 (PN 8335) please complete the attached Response form with the quantity in inventory and return the form to Richard-Allan Scientific. The product may be used and no further action is required. ¿ If the product is labeled as Type 6 (PN 8336) please complete the attached Response form with the quantity in inventory. The product may be used as is or returned to Richard-Allan Scientific. Please indicate on the Response form if the product will be used or a return is desired. Return the completed form to Richard-Allan Scientific. ¿ If affected product has been used previously, please complete the attached Response form with the quantity that was used. No further action is required. By returning the attached Acknowledgment Form will facilitate reporting of this matter to the FDA. Customers with questions were instructed to call 269-544-5628.


  • Modelo / Serial
    Product code: 8335 and lot code: 348248
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution to AZ , CA , FL , GA , IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom. 6 distributed to OUS accounts: Germany, and the United Kingdom
  • Descripción del producto
    Richard-Allan Scientific Paraffin Type 3 || For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place
  • Manufacturer


  • Dirección del fabricante
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Empresa matriz del fabricante (2017)
  • Source