Events

Retiro De Equipo (Recall) de ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SOMAGEN DIAGNOSTICS 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
    92233
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-13
  • 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
    Affected batches are positive for antibodies to hiv 1 and/or hiv 2 despite a claim on the package insert that the product is manufactured from serum or plasma that is negative for antibodies to hiv 1 and 2. there is no impact on the performance of the affected batches and the anti-hiv 1/2 positive stock used to manufacture the accurun 51 products us treated with beta propiolactone and uv radiation to reduce virus activity minimizing any safety risk.

Device

ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1
  • Modelo / Serial
    Model Catalog: 2000-0041 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10164524); Model Catalog: A51-5001 (Lot serial: Batch 10164524); Model Catalog: A51-5005 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10231486); Model Catalog: 2000-0041 (Lot serial: Batch 10231486); Model Catalog: A51-5001 (Lot serial: Batch 10231486); Model Catalog: A51-5005 (Lot serial: Batch 10231486); Model Catalog: 2000-0040 (Lot serial: Batch 10164525); Model Catalog: 2000-0041 (Lot serial: Batch 10164525); Model Catalog: A51-5001 (Lot serial: Batch 10164525); Model Catalog: A51-5005 (Lot serial: Batch 10164525); Model Catalog: 2000-0040 (Lot serial: Batch 10231487); Model Catalog: 2000-0041 (Lot serial: Batch 10231487); Model Catalog: A51-5001 (Lot serial: Batch 10231487); Model Catalog: A51-5005 (Lot serial: Batch 10231487)
  • Descripción del producto
    ACCURUN 51 Multi-Marker Hepatitis Positive Control;ACCURUN 51 Multi-Marker Hepatitus Positive Control
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Dirección del fabricante
    EDMONTON
  • Empresa matriz del fabricante (2017)
    Diploma Plc
  • Source
    HC