Events

Retiro De Equipo (Recall) de SALMONELLA AGGLUTINATING SERUM O POLY A-S

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PRO-LAB DIAGNOSTICS.

¿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
    95780
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-06-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The overall performance of the antisera has deteriorated and this is more marked in some factors than others. the product was deemed not fit for purpose as it had deteriorated since being put on the market. it was still agglutinating with most salmonella cultures tested against but was slower against some of the higher somatics as it is not detecting within one minute which is stated in the instructions for use.

Device

SALMONELLA AGGLUTINATING SERUM O POLY A-S
  • Modelo / Serial
    Model Catalog: PL 6002 (Lot serial: 1335)
  • Descripción del producto
    Salmonella Agglutinating Serum O poly A-S
  • Manufacturer
    PRO-LAB DIAGNOSTICS

Manufacturer

PRO-LAB DIAGNOSTICS
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Pro-Lab Diagnostics
  • Source
    HC