Events

Retiro De Equipo (Recall) de Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin

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
    Recall
  • ID del evento
    74557
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2351-2016
  • Fecha de inicio del evento
    2016-06-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147901
  • 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
    Formalin, neutral buffered - Product Code IFP
  • Causa
    Potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. it is unknown whether the contamination will affect tissue antigenicity. if it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. there is the possibility the patient may need to be re-biopsied.
  • Acción
    On 6/13/2016, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via certified mail with instructions for identifying and disposing of the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin
  • Modelo / Serial
    Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of FL, PA, NY, MD, CA, and AZ.
  • Descripción del producto
    Richard Allan Scientific 10% Neutral Buffered Formalin, || Part Number: 53901 and 561201 || Item 53901 90ml bottle, 125 per case; || Item 561201 120ml bottle, 75 per case.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

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